Medical Devices

Overview

Due to the rise of complex technologies and constant changing of regulatory environment regulatory professionals in the Medical Device Industry are facing more challenges. In addition to keeping up with these changes, regulators must also define the correct pathway for incoming registered products. Global Regulatory Partners Inc. has a global presence with teams of local experts who can develop the appropriate regularly intelligence, strategy and pathway for the registration of your device in different markets.

Authorized Local Agent

Global regulatory Partners, Inc. (GRP) has local offices and strategic partners worldwide that are licensed by local authorities to act as your local agent in many countries for your medical devices and in-vitro diagnostics.

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., 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.

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 Strategy

Developing the right regulatory strategy for your products in different markets is crucial for successful product development, registration, and commercialization. Global Regulatory Partners, Inc., (GRP) team has expertise in developing the appropriate and effective regulatory strategy for different types of products and for different markets. Our strategy will help you meet your business objectives and goals and reduce your risk of failure.

In developing the regulatory strategy, our team takes into consideration different factors such as information on your products and similar products on the market, your product development status and milestones, your business goals and timelines, the regulatory requirements related to your product, cost, and risk assessment.

With a global presence and a local team of experts, GRP regulatory strategy will give you confidence in the forecast of key milestones, a list of the necessary documentation needed for product development and registration, timelines and cost of the different activities, and action plan to meet your milestones.

Medical Product Registration

Medical device registration and continued maintenance in multiple countries is a very challenging task. Each country has its own regulatory authority reinforcing compliance to its own regulatory requirements and quality standards. Moreover, some countries require all registration documents translated into their native language before submission such as China, Korea, Japan, Brazil and Mexico.

Global Regulatory Partners (GRP) Regulatory Affairs team has the expertise, long-term experience preparing and compiling the registration dossiers for all categories of medical devices and IVDs in line with the latest regulatory requirements in multiple countries before submitting them to the appropriate health authorities.

Through many years of operation, the GRP Regulatory Affairs team has established close working relationships with health authorities in many countries. GRP has developed regulatory and technical skills to assist medical device and IVD companies register their products efficiently anywhere in the world.

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 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

In general, it is highly recommended to have a pre-consultation meeting with health authorities such as FDA, EMA, PMDA , ANVISA, NMPA , TGA during the development of new pharmaceutical or biologic products. Consultation meetings 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.

Global Regulatory Partners Inc., (GRP) regulatory affairs team has the expertise in preparing consultation meeting with different heath authorities before starting key milestone of your product development such as

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 plan, 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 over 100 consultation meeting with different health authorities in different markets

Clinical

Our professionals apply their therapeutic, regulatory, and operational expertise to consistently make sure that your clinical studies are conducted with ICH guidelines and other applicable regulatory requirements.
In an increasingly challenging environment, we have the experience and knowledge to find, recruit, and retain patients in clinical trials. We successfully deliver access to appropriate sites and patients, developing strategies that will minimize the risks inherent in-patient recruitment.

Our clinical services for national and/or international multi-site trials includes:

  • Protocol development
  • Site and investigator identification and qualification
  • Site initiation and training
  • Clinical monitoring
  • Medical monitoring
  • DSMB coordination
  • Statistical analysis
  • Electronic data capture
  • Electronic Trial Master File
  • Full- service data management
  • ClinicalTrials.gov registration and management
  • Central lab oversight and coordination
  • Site quality assurance audits
  • Integrated final Clinical Study Report
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