Pharmaceuticals

Overview

Global Regulatory Partners, Inc.,(GRP) provides end-to-end regulatory affairs services that allow our clients register their drug, biologic or generic products in different countries at record time. Our regulatory services include regulatory intelligence, regulatory strategy, regulatory operations and publishing, products’ registration and products’ life cycle management.

Through our local offices in USA, Latin America and Asia, GRP can act as your local authorized agent  in different countries and our regulatory team can support your company throughout the whole products’ lifecycle, ensuring compliance with local regulations and providing vital scientific and strategic advice from products’ development till commercialization.

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 pharmaceutical products.

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.

Global Regulatory Partners Inc., a team of professionals can provide you with tailored Regulatory Intelligence that includes the latest regulatory information and recommendations for the commercialization of your Pharmaceutical or Biologic products in different markets.

Regulatory Affairs

Global regulatory Partner, Inc., (GRP) provides a full regulatory affairs services to Pharmaceutical and Biologic companies globally, from their products’ development and  registration till commercialization.

GRP regulatory affairs services include regulatory intelligence, regulatory strategy, regulatory operations and publishing, product’s registration, products’ life cycle management and maintenance.

Regulatory Strategy

Developing the right regulatory strategy for your pharmaceutical or biologic products for different markets is crucial for having a successful products’ development, registration, and commercialization process.

Global Regulatory Partners, Inc., (GRP) team has the expertise in developing the appropriate and effective regulatory strategy for different types of products and for different markets, that will help you meet your business needs and goals and reduce your risk of failure.

In developing the regulatory strategy, GRP team takes into consideration different factors such as information on your product and similar ones on the market, your product development status and milestones, your business goals, your timelines, the applicable regulatory requirements, operations costs, and analysis of potential risk assessment that may occur during your product development, or registration or commercialization.

With a global presence and local team of experts, GRP regulatory strategy will provide you the correct regulatory pathway for your product development and registration in different markets. Based on GRP regulatory strategy , you can forecast with confidence your key milestones, as you received the list of the necessary documentation needed for your products’ development and registration, the timelines and cost of the different activities, and action plan to meet your milestones.

Regulatory Operations and publishing:

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

Global Regulatory Partners Inc. (GRP) 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.

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.

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.

Medical Writing

Medical writing involves writing scientific documents of different types which include regulatory and research-related documents, disease or drug-related educational and promotional literature.

Global Regulatory Partners Inc, (GRP) medical writers have the expertise in presenting the collected scientific information in a suitable way so it can be understood by different target audience, namely, health authorities, patients or general public, physicians or the regulators. GRP Medical writers understand the medical concepts and terminology, knowledge of relevant guidelines as regards the structure and contents of specific documents, and good writing skills.

Product registration

Global Regulatory Partners Inc., (GRP) offers a full service for Pharmaceutical and biologic products registration in different countries in line with local regulations. Pharmaceuticals companies, certainly those developing new technologies, quickly discover the demanding and complex regulatory process required from health authorities (HA). Global Regulatory Partners Inc. (GRP), has local teams of regulatory experts that work with worldwide health authorities (HA) constantly such FDA, EMA, CFDA, ANVISA, TGA, and PMDA.

GRP Inc has long-term experience successfully preparing, compiling and submitting to HA, dossiers of pharmaceutical and biologic products from different therapeutic areas despites the complexity of their technologies.

GRP RA team will prepare and submit the responses to health authorities’ queries as needed and will provide the necessary regulatory support till you receive the formal application approval. After approval, GRP RA team will maintain your IND/CTA application or your Marketing Authorization by providing the following services.

GRP Submission Services:

    • IND submissions
    • NDA submission
    • MAA submission
    • DMF submission
    • CTA submission
    • Life cycle management
    • Annual Report
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