South Korea. The ministry of Food and Drug Safety.

Medical Devices

MFDS Medical Device Regulations:

Medical Devices in South Korea (S. Korea) are regulated by the Ministry of Food and drug safety (MFDS) formerly known are the Korean Food and Drug Administration (KFDA). Registering medical devices and IVD in S. Korea is a complex and challenging process. Most of MFDS regulations are not written clearly and some are only available in the Korean language.Defining the right regulatory strategy to be able to navigate through the challenging regulatory pathway is essential for successful products’ registration in S. Korea.

GRP Medical Device Services:

Global Regulatory Partners Inc. (GRP) has a global presence with a team of local experts in South Korea who can develop the appropriate regularly intelligence, strategy and pathway for the registration of your device in the South Korea’s market.

More Resources:

  • MDFS. Medical Devices.
  • For access to more information please click on the ‘ Read More‘ tab. 

Authorized local agent

In South Korea, the holder of a medical product registration must be a Korea-based entity. This entity is called the In-Country Caretaker (ICC). Foreign medical companies without their own local Korean office and who do not want to use their distributor as their local agent can have an independent ICC in South Korea maintain their product registrations in the name of the foreign manufacturer. Written below are brief bullet points on the responsibilities of an ICC.

RESPONSABILITIES OF ICC

  • An ICC in S. Korea is responsible for applying to the Ministry of Food and Drug Safety (MFDS) for product approval.
  • An ICC ensures that labeling is accurately added to the product (in Korean), documenting and reporting adverse events or product failures, etc.
  • An ICC can also act as a liaison between the foreign manufacturer and its S. Korean distributor. Distributors usually require data from foreign manufacturers so they can be certified for Korean Good Import Practice, and an ICC can coordinate these requests.

GRP Local Agent Services in South Korea:

  • Communication with the MFDS
  • Assistance with MFDS inspections
  • Adverse Effect Reporting
  • Importation of products
  • Organize and support MFDS consultation meetings
  • Product registration
  • Support importation process
  • Post-market vigilance
  • Manage Distributors

Regulatory intelligence

Regulatory intelligence (RI) is an essential tool for regulatory professionals. RI allows professionals to develop the most appropriate regulatory strategy for a successful, efficient, and cost- effective product development, registration, and commercialization. Due to the continuously evolving nature of the Regulatory environment, it is becoming more challenging for regulatory professionals to stay up-to-date and collect the appropriate RI related to their product in a timely manner.

At Global Regulatory Partners Inc., (GRP) a team of professionals can provide you with tailored Regulatory Intelligence that includes the latest regulatory information and our recommendations for the most appropriate and effective strategy to address your particular- needs in South Korea.

Regulatory Strategy

Registering medical devices and IVD in South Korea is a complex and challenging process. Most of MFDS regulations are not that clear, are in Korean language and are changing constantly. Defining the right regulatory strategy to be able to navigate through the challenging regulatory pathway is essential for successful products’ registration in South Korea.

Our regulatory team in South Korea has the expertise in developing effective and tailored regulatory strategies that helped many foreign medical device companies to register their products quickly and efficiently.

GRP’s Medical Device Regulatory Strategy Services in  South Korea:

  • Identify and the latest regulatory requirements related to your medical device or IVD.
  • Proactively identify challenges or issues that may delay the approval of your medical device in South Korea.
  • Identify potential risks and obstacles so that you can avoid any unexpected roadblocks during the registration process.
  • Propose innovative solutions and approaches to circumvent these challenges ahead of time.
  • Identify the most cost-effective way to get your medical product registered in South Korea.

Regulatory Affairs

Global regulatory Partner, Inc., provides a full regulatory affairs service from product concept throughout product development till product registration.

Our regulatory affairs services include regulatory intelligence, regulatory strategy, regulatory operations, and publishing; product registration, registration amendments; consulting meetings with regulatory authorities.

Our Regulatory affairs teams help medical device companies understand and efficiently manage the demanding complexity of the diverse Regulatory requirements in  South Korea so they can  successfully register and commercialize their products in South Korea’s market and maximize the value of their assets.

Product registration

The first step in the registration process is the determination of the classification of your device according to the rules found in MFDS Notification No. 2014-110.

In South Korea (S. Korea), medical devices are classified as Class I, Class II, Class III or Class IV based on increasing risk. A database including medical device descriptions, classifications and categories can be found on the MFDS website. The registration of medical device in S. Korea will vary depending on device classification and the existence of a predicate device registered in S. Korea. 

Low Risk Class I Medical Devices:

  • Subject to Pre-Market Notification (PMN). 

Class II medical devices : ( There are 2 regulatory pathways)

  • With a registered predicate (Substantial Equivalent), product registration applications qualify for third party review of the medical device and quality systems conformity assessments.
  • All other Class II devices are subject to a Safety and Efficacy Review by the MFDS with an 80-day processing time.

Class III and Class IV devices:

  • subject to Pre-Market Approval (PMA) with applications reviewed by the MFDS.  The Substantial Equivalent review pathway takes 65 days and while the Safety and Efficacy Review pathway takes 80 days

In South Korea, some medical devices may be classified as “quasi-drug” or “drug” even though the same products are classified as medical devices in the US or EU.

Our regulatory team in South Korea has the expertise in local regulatory requirements and regulatory processes needed to get medical devices and IVDs registered efficiently within KFDA.

Table 1: MEDICAL DEVICE CLASSIFICATION AND REGISTRATION TYPE IN SOUTH KOREA

Device Class Description Type of Registration
Class I Low risk Pre-Market Notification
Class II Medium risk 2 Possible Registration Pathways:
• Substantial equivalent
• Safety and efficacy Review
Class III Medium-high risk Pre-Market Approval
Class IV High risk Pre-Market Approval
Device Class General Considerations for Medical device Registration in Korea
Class I Applications are submitted to the MDITAC (Medical Device Information & Technology Assistance Center) through the MFDS e-submission systems and are considered accepted upon submission. A PMN number is issued on notification. § The Pre-Market Notification should include basic device information. § All documents must be translated into the Korean language.
Class II (Special Equivalent) There are approximately 350 Class II devices that MFDS considers “Special Equivalent,” which require a less robust application, i.e. no Technical File, as well as an expedited review by a Third Party Reviewer For Class II medical devices, pre-market approval procedures mainly depend on the device’s level of Substantial Equivalency (SE) with previously approved products. Medical devices are divided into four categories according to the KFDA SE standards:
1. Announced Equivalent product
2. Equivalent product
3. Improved product
4. Novel product.
Announced Equivalent products are not subject to technical document review. Medical devices in the other three SE categories must go through the technical documents review process. Definitions and criteria to determine SE categories can be found in the revised Medical Device Act and on the KFDA website.
Class II, III & IV §General Technical File OR Safety and Effectiveness Review (SER) should be prepared and submitted to KFDA or a Third Party for Review. § Clinical data must be included in these submissions. The MFDS may accept clinical data obtained in other markets. § All documents must be in Korean.
• Local type testing for Class II, III, and IV devices may be required for registration if there are no equivalent foreign test reports. Local type testing is conducted by an independent laboratory (Korea Testing Lab is authorized to conduct type testing).
§ The foreign medical device company and the Korean License Holder must comply with Korea Good Manufacturing Practice (KGMP) quality system requirements. § KGMP certification includes an on-site audit of foreign manufacturing facilities. § KGMP certificate is issued by KFDA and is valid for 3 years. § KGMP certification is now required before product registration. § Pre-Market Approval license is issued by KFDA and does not have an expiration date. § Approval in the Country of Origin is not required for registration in Korea.

Our regulatory team in South Korea has the expertise in local regulatory requirements and regulatory processes needed to get medical devices and IVDs registered efficiently within MFDS.

Related Links:

MFDS. Medical Devices. https://mfds.go.kr/eng/wpge/m_39/denofile.do

Quality

One major step for companies registering medical devices in South Korea is compliance with the Korea Good Manufacturing Practice (KGMP) quality system regulations. Similar to ISO 13485 quality system standards, KGMP is required by the Korean Ministry of Food and Drug Safety (MFDS) for all Class II, III, and IV medical devices. MFDS will verify KGMP compliance via onsite inspections, conducted either by its own staff or with the assistance of Third-Party Auditor.

KGMP AND KOREA QUALITY MANAGEMENT FOR MEDICAL DEVICES

KGMP certification must be secured before any medical device company can sell any Class II, III and IV medical devices on the South Korean market. To obtain KGMP certification, medical device companies must submit documentation to MFDS or authorized third party auditor, to demonstrate that their medical devices comply with KGMP quality system requirements.

Following submission of KGMP certification application, companies’ manufacturing site will likely undergo inspection by a qualified third-party auditor and/or MFDS depending on devices’ classification:

  • For Class II medical devices, manufacturing sites are subject to third-party audits only.
  • For Class III and IV devices, manufacturing sites are subject to a combined audit by a third-party reviewer and MFDS.

As of 2015, companies must undergo KGMP auditing at the beginning of product registration, rather than after the product is approved by the MFDS. Furthermore, in vitro diagnostic (IVD) products are now regulated as medical devices instead of pharmaceuticals. IVD manufacturers must therefore comply with KGMP requirements as well.

Our quality team in South Korea has the expertise in compiling and submitting to MFDS the application for KGMP certification in line with MFDS quality standards.

Clinical

When medical devices are registered in reference foreign countries, such as US, EU, Canada and Japan, foreign clinical trial data is usually accepted by the MFDS. Local clinical trials are generally not required for device approval, except for certain Class IV medical devices.

The MFDS prefers foreign clinical trial data published in a professional journal. However, they will accept unpublished data if the studies were conducted by an acceptable research organization that followed Good Clinical Practice (GCP).

Requirements for Approval of Clinical Trial Applications

In order to submit a clinical trial application (CTA) for a medical device in S. Korea, foreign companies must first prepare a clinical investigation plan, along with documents proving that Good Manufacturing Practice (GMP) standards are met by the foreign company’s manufacturing facility.

If the device is used to treat life-threatening illnesses, a series of supplementary documents must be sent to the Investigational Review Board (IRB) for approval as well.

Medical devices trials normally take only 30 days to be approved in S. Korea.

Electronic Filing System (KiFDA)

Korea’s clinical trial registration process – filing and submitting pre and post approval registration forms – is now online. After the medical device is approved, the e-registration system is available for applicants and CROs.

GCP Requirements for Conducting Clinical Trials in Korea

Good clinical practice in Korea (K-GCP) is aligned with international guidelines (ICH-GCP).

Adverse events must be submitted to the MFDS by manufacturers, distributors, and clinics, among others. If the incident resulted in death or life-threatening injuries, a report must be filed within seven days, with a follow-up eight days later. Events causing hospitalization, disability, or deformity must be reported within fifteen days. All other adverse events must be reported within thirty days.

After clinical trials in Korea are completed, companies should file a report to the MFDS, including all data, therapeutic effects, and adverse events from the trial.

Our clinical team in South Korea has the expertise in obtaining the CTA approval from MFDS and manage clinical trials for medical device companies efficiently.

Medical writing

Medical Writing is an important function of regulatory affairs. It plays a critical role in the development and preparation of regulatory documents and defines the success or failure of new products in South Korea. As the MFDS Regulatory authorities expect precise, clear and well-written documents, any bad writing or translation can raise health authorities queries and consequently delay product approval. Global Regulatory Partners, Inc., has a team of professional medical writers who can write regulatory and clinical documents in Electrical Common Technical Documents (eCTD) and CTD modules.

Health authority consultation

Consultation meetings with the MFDS can serve as a valuable tool to discuss needs and challenges specific to the development of the product and design of their proposed nonclinical studies. Sponsors can also discuss their Chemistry, Manufacturing and Controls (CMC) development plan and discuss their overall development plan.

GRP regulatory affairs team supports includes: writing, preparation and submission of the meeting package to the health authority, prepare the questions to health authority based on the status of your product’s development and future, provide support during the meeting, write the meeting minutes and develop the appropriate action plan after the consultation meeting.  GRP regulatory affairs team has organized and supported numerous consultation meeting with the MFDS health authorities.

Pharmaceuticals

MFDS Drug Regulations:

South Korea’s regulatory systems are diverse, and oftentimes challenging to navigate. The South Korean regulatory agency, the Ministry of Food and Drug Safety (MFDS), has its own set of regulations and customary manner of conducting business. Thus, determining the most effective and efficient strategy to obtain approval for your pharmaceutical product(s) without sufficient knowledge and experience with the S. Korean regulatory authorities can become exhaustive and costly.

Medicinal Product

In S. Korea a “medicinal product” is defined under the Pharmaceutical Affairs Act as  to be “used for the purpose of diagnosis, medical care, alleviation, treatment or prevention of diseases of human beings or animals, excluding appliances, machinery or equipment.”

Quasi-Drug

In S. Korea a “Quasi-drug ” is defined under the Pharmaceutical Affairs Act as;

(a) Fibers, rubber products or similar products used for the purpose of treating, alleviating, or preventing human or animal diseases;
(b) Non-appliance, non-machinery or similar articles which act slightly upon or do not directly act upon human bodies;
(c) Preparations used for sterilization, insecticide and uses similar thereto for the purpose of preventing communicable diseases.

GRP Pharmaceutical Services:

Global Regulatory Partners Inc. (GRP) has a global presence with a team of local experts in South Korea who can develop the appropriate regularly intelligence, strategy and pathway for the registration of your drug in the South Korea’s market.

More Resources:
  • MDFS. Drugs.
  • For access to more information please click on the ‘ Read More‘ tab. 

Authorized local agent

In South Korea, the holder of a medical product registration must be a S. Korea-based entity. This entity is called the In-Country Caretaker (ICC). Foreign medical companies without their own local Korean office and who do not want to use their distributor as their local agent can have an independent ICC in Korea maintain their product registrations in the name of the foreign manufacturer.

South Korea. The ministry of Food and Drug Safety.

GRP Local Agent services in South Korea:

  • Communication with the MFDS
  • Assistance with MFDS inspections
  • Adverse Effect Reporting
  • Importation of products
  • Organize and support MFDS consultation meetings
  • Product registration
  • Product storage in an establishment with ICC licensing
  • Support importation process
  • Post-market vigilance
  • Manage Distributors

RESPONSABILITIES OF ICC

  • An ICC in Korea is responsible for applying to the Ministry of Food and Drug Safety (MFDS) for product approval, making sure that Korean labeling is accurately added to the product, documenting and reporting adverse events or product failures, etc.
  • An ICC can also act as a liaison between the foreign manufacturer and its Korean distributor. Distributors usually require data from foreign manufacturers so they can be certified for Korean Good Import Practice, and an ICC can coordinate these requests.

Regulatory intelligence

Regulatory intelligence (RI) is an essential tool for regulatory professionals. RI allows professionals to develop the most appropriate regulatory strategy for a successful, efficient, and cost- effective product development, registration, and commercialization.

At Global Regulatory Partners Inc., a team of professionals can provide you with tailored Regulatory Intelligence that includes the latest regulatory information and our recommendations for the most appropriate and effective strategy to address your particular- needs in South Korea.

Regulatory Intelligence| Global Regulatory Partners Inc.

Regulatory Strategy

South Korea’s regulatory systems are diverse, and oftentimes challenging to navigate.  Thus, determining the most effective and efficient strategy to obtain approval for your pharmaceutical product from each regulatory body without sufficient knowledge and experience with Asian regulatory affairs can be a very difficult task.

Our regulatory team in South Korea has the expertise in developing effective and tailored regulatory strategies that helped many foreign pharmaceutical companies to register their products quickly and efficiently.

GRP’s Pharmaceutical Regulatory Strategy Services in South Korea:

  • Identify and the latest regulatory requirements related to your pharmaceuticals, biologics, biosimilars and generics.
  • Proactively identify challenges or issues that may delay the approval of your pharmaceutical in South Korea.
  • Identify potential risks and obstacles so that you can avoid any unexpected roadblocks during the registration process.
  • Propose innovative solutions and approaches to circumvent these challenges ahead of time.
  • Identify the most cost-effective way to get your pharmaceutical product registered in South Korea.
Regulatory Affairs | Global Regulatory Partners

Product registration

The Korean Ministry of Food and Drug Safety (MFDS), formerly the Korea Food and Drug Administration (KFDA), is the main regulatory body for drug registration and approval.

Korean Pharmacopoeia (KP)

The Korean Pharmacopoeia (KP) is a pharmaceutical order implemented by the Korean government with regard to the improvement of public health. The KP defines the standard for quality and safety, hence drugs stated by the KP are acknowledged to be safe and efficacious in the treatment and prevention of diseases. The classifications for pharmaceuticals are as follows:

  • Drug products that do not require a safety and efficacy review– Drugs that have already been deemed safe and efficacious or are listed in the Korean and U.S. Pharmacopeia. These drugs only require a MFDS notification submission.
  • Drug products that require a safety and efficacy review, and intensive management– Drugs that require a review and approval to prevent risk factors

 

MFDS DRUG REGISTRATION PATHWAYS

For new drugs:

  • Submit investigational new drug (IND) application to the MFDS.
  • The MFDS conducts the IND application review.
  • Submit new drug application (NDA) to the MFDS.
  • If the MFDS does not require supplementary data, the NDA is approved.
  • Prepare the application dossier for drug approval.
  • Submit the application to MFDS Management Division for Drug Approval & Review.
  • The MFDS conducts an initial assessment of the application, generates a report outlining the application dossier, and submits it to the MFDS Drug & Evaluation Department.
  • The Drug & Evaluation department conducts a review of the following, including: results of the initial assessment, technology, safety & efficacy data, product standards, clinical trial data, good manufacturing practice (GMP) data, Drug Master File (DMF) data, impacts on intrinsic (genetic) factors, and extrinsic (factors) etc.
  • If no further documentation or supplementary data is required, The MFDS issues the applicant a Certificate of Approval.

For API Products:

Drug Master File (DMF) preparation: The MFDS requires registration of certain substances, which are subject to DMF registration. A DMF will often contain confidential information on facilities, materials, processes, and packaging. By submitting a DMF to the MFDS, the registered manufacturer can then refer importers or distributors to the registration number without disclosing confidential information to Korean business counterparts.

  • Application submission: Applicants who wish to register their API may submit their application via the Korea Drug Master File (KDMF). Foreign manufacturers of these drug substances or products containing these substances can submit a DMF through a Korean importer or third-party representative with a Korean address. Domestic manufacturers can submit a DMF to the MFDS directly.
  • Once a DMF is submitted, the MFDS will review the documents and conduct a facility inspection. Most applications will need to undergo a facility inspection prior to receiving approval.
  • Once the application is approved, the MFDS will send a letter of acceptance and publicize the names of the DMF sponsors and registered substances. The timeframe is approximately 5-6 months, however, can extend to 8-9 months depending on the current capacity of the MFDS.

The application dossier generally includes:

  1. Origin or backgrounds leading up to discovery and development.
  2. Product structure (physical, chemical, biological) nature
  3. Stability test data
  4. Toxicity data
  5. Pharmacologic effects
  6. Clinical data – New products must fulfill the requirements of the MFDS New Drug Application (NDA)
  7. Uses in other countries (if applicable)
  8. Comparison with similar domestic products (if applicable)

Use of foreign clinical data

Foreign clinical data that meet any of the following requirements may be substituted for drug safety/efficacy data:

(1) Documents or notarial writings which confirm that submitted clinical study data were already submitted to or approved by competent regulatory authorities (of approval or registration) in other economies
(2) Data that are published in a specialized academic journal listed in the Science Citation Index (SCI)
(3) Data that verify the reliability of clinical trial institution and compliance with Good Clinical Practice (GCP)

Regulatory Affairs

Global regulatory Partner, Inc., provides a full regulatory affairs service from product concept throughout product development till product registration. Our regulatory affairs services include regulatory intelligence, regulatory strategy, regulatory operations, and publishing; product registration, registration amendments; consulting meetings with regulatory authorities.

Our Regulatory affairs teams help medical device companies understand and efficiently manage the demanding complexity of the diverse Regulatory requirements in order to successfully register and commercialize their products in new markets and maximize the value of their assets.

Regulatory Operations

Global Regulatory Partners Inc., (GRP) offers full electronic submission services from eCTD preparation, publishing and submission activities in South Korea.  GRPs dedicated team of experts ensures the quality and validity of the dossier submissions in accordance to the technicalities of regional eCTD requirements.

GRP’s Regulatory operation services include consulting services, planning and assembly of submissions, document creation and approval, e-Submission roadmap compliance, publishing, viewing and navigation, archiving, submission process optimization, tracking and lifecycle management.  GRP remains in compliance by implementation of Regulatory Information Management (RIM) with XEVMPD and IDMP requirements.  GRP will facilitate and coordinated management of all paper and electronic submissions, both eCTD and non-eCTD electronic submissions, and ensure timely submissions.

Medical writing

Medical Writing is an important function of regulatory affairs. It plays a critical role in the development and preparation of regulatory documents and defines the success or failure of new products. As Regulatory authorities expect precise, clear and well-written documents, any bad writing can raise MFDS authorities queries and consequently delay product approval. Global Regulatory Partners, Inc., has a team of professional medical writers who can write regulatory and clinical documents in Electrical Common Technical Documents (eCTD) and CTD modules.

Medical writing | Global Regulatory Partners

Health Authority Consultation

Consultation meetings with the MFDS can serve as a valuable tool to discuss needs and challenges specific to the development of the product and design of their proposed nonclinical studies. Sponsors can also discuss their Chemistry, Manufacturing and Controls (CMC) development plan and discuss their overall development plan.

GRP regulatory affairs team supports includes: writing, preparation and submission of the meeting package to the health authority, prepare the questions to health authority based on the status of your product’s development and future, provide support during the meeting, write the meeting minutes and develop the appropriate action plan after the consultation meeting.  GRP regulatory affairs team has organized and supported numerous consultation meeting with the MFDS health authorities.

Clinical

Conducting clinical trials in South Korea:

Conducting clinical trials in South Korea is cost effective, and the data generated is well regarded internationally. GRP can help pharmaceutical manufacturers assess the suitability of South Korea as a site for conducting clinical trials for their drug. We also provide assistance in researching and analyzing the appropriate clinicians and institutions and in screening CROs as prospective clinical trial managers in South Korea. 

To obtain approval for clinical trials in S. Korea, companies must go through the clinical trial authorization (CTA) process. Before beginning the pharmaceutical clinical trial in Korea, applicants must choose trial sites and a Principal Investigator (PI). Korean PIs must be well educated, trained, and have foreign language abilities. The sponsor and head of the clinical trial site will sign a written contract before the trial begins. If a CRO is used, the sponsor must write a contract outlining a set of tasks for the CRO to complete.

In order to conduct the clinical trial itself, companies must execute further steps, including receiving approval from an Institutional Review Board (IRB), recruiting subjects and trial personnel, and ensuring quality standards, etc. Companies should use the MFDS consulting services for pre-investigational new drugs in order to determine which documents will be needed. All documents submitted by the sponsor for the clinical trial authorization (CTA) should be in Korean.

Clinical Trial Centers 

There are a total of 166 clinical trial centers designated by MFDS, providing diverse and robust environments for clinical trials.

Prior Review:

“Prior review” is review of documentation required for drug approval and notification by the MFDS prior to the submission for approval or notification of pharmaceuticals or approval of clinical trials and bioequivalence test. Prior Review usually required the follwing documentation:

(1) Safety/efficacy data
(2) Specification and test methods
(3) GMP data
(4) Clinical trial protocol
(5) Bioequivalence test protocol
(6) Pharmaceutical development plan
(7) Other required data for drug approval/notification, IND approval, and approval of bioequivalence test protocol

Electronic Filing System (KiFDA)

Korea’s drug clinical trial approval forms can now be submitted through the e-registration system. Applicants and CROs can self-register their products after receiving approval.

GCP Requirements for Conducting Clinical Trials in S. Korea

Good clinical practice in Korea (K-GCP) is aligned with international guidelines (ICH-GCP).

Adverse events must be submitted to the MFDS by manufacturers, distributors, and clinics, among others. If the incident resulted in death or life-threatening injuries, a report must be filed within seven days, with a follow-up eight days later. Events causing hospitalization, disability, or deformity must be reported within fifteen days. All other adverse events must be reported within thirty days.

After clinical trials in S. Korea are completed, companies should file a report to the MFDS, including all data, therapeutic effects, and adverse events from the trial.

GRP Clinical Trial services for  in South Korea:

Assess qualification of clinicians, institutions and CROs

  • Evaluate track record of clinicians and institutions for the type of devices to be investigated.
  • Assist in creating awareness of manufacturer’s product with key clinicians and facilitate relationship between clinicians and manufacturer.
  • Regulatory and product compliance requirements.
  • Research IRB and Trial Indemnity requirements.

CRO qualification and selection

  • Thorough pre-qualification of Australian CRO based on needs.
  • Intensive screening of CRO and level of experience, service level, etc. based on manufacturer’s criteria.
  • Intensive one-on-one interviews to determine a “short list” of qualified candidates.
  • Final selection is based on your comfort level and objectives.

Manage Clinical Trials

  • Liaison between your company and your appointed CRO in South Korea.
  • Assistance with troubleshooting.
  • Contact and visit your  CRO to assess progress.
  • Provide the manufacturer with independent reports on patient recruitment, trial progress and issues.
  • Represent the manufacturer in any liaison activities with clinicians or institutions as required