The Medpace Global Regulatory Affairs team works collaboratively with sponsors and clients on a country, regional and global basis to help accelerate the global development of safe and effective medical therapeutics.
Our team has extensive experience covering pre-marketing and post-marketing regulatory strategies for a wide range of medical therapeutics, including drugs, biologics and medical devices worldwide.
Medical Writing Services At A Glance:
- Investigational and marketing applications
- Summary document preparation
- Protocols
- Clinical Study Reports (CSRs)
- Investigator’s Brochures (IBs)
- Investigational Medicinal Product Dossier (IMPDs)
Medpace’s medical writing group can support your clinical trial documentation needs by developing protocols, protocol amendments, and clinical study reports from the early phases of development through to post-approval. Our writers efficiently craft effective and implementable quality protocols and CSRs that align with your vision and goals. A cross-functional team actively contributes to and reviews documents during established review cycles including the Medical Monitor, Biostatistician, and Clinical Trial Manager.
Our dedicated team of medical writers:
- Have advanced degrees including PharmD, MD, PhDs with backgrounds in Medpace’s core therapeutic areas
- Manage all document development including coordination of internal reviews, Sponsor correspondence, timelines, and quality control
- Facilitate collaboration across functional areas to incorporate varying perspectives and considerations
- Execute our robust quality control process which requires certification in seven areas
- Work directly with your assigned Medpace medical monitor, who is an active part of the project leadership team, on document preparation
Strategic Development Services At A Glance:
- Gap Analysis
- Understand how regional regulatory requirements will be applied to your product
- Determine your level of readiness to move to your next step, identify gaps and develop effective mitigation strategies
- Target Product Profile (TPP)
- Identify the necessary characteristics of your product to address an unmet clinical need
- Protocol Synopsis Development and Review
- Assess the acceptability of your clinical trial design and accepted end points to regulatory agencies
- Interactions with Regulatory Authorities
- Increase efficiency of your product development program
- Prevent clinical hold issues from arising
- Special Designations and Accelerated Paths to Market
- Considerations for pediatric plans, orphan drug designations, break through therapy, PRIME, fast track and other relevant programs for your product
Partner with our experienced regulatory experts to navigate the final steps of your pre-clinical program, transition to clinical development and advance to pivotal clinical studies and market authorization. Our global regulatory affairs team collaborates with clients at any stage of clinical development in formulating and implementing regulatory strategies for product development and pathways to market.
Document Preparation & Submission Services At A Glance:
- Overview and summary document preparation
- e-CTD preparation, compilation and e-publishing
- Electronic submission to Regulatory Authorities
- Submission maintenance and regulatory compliance
Our team of global regulatory experts conduct electronic publishing of regulatory documents and dossiers in eCTD format while facilitating submission to regulatory agencies via electronic gateways.
Preparation & Submission of Investigational New Drug and Clinical Trial Applications:
- Document development, e-publishing and submission of clinical trial applications including:
- Modules 1 through 5 for US IND as per the ICH eCTD specifications to the FDA
- Investigational Medicinal Product Dossier (IMPD) for EU CTA and UK CTA
- Review and/ or development of Quality Overall Summary (Module 2.3), Non-Clinical Overview (Module 2.4), Non-Clinical Written and Tabulated Summaries (Module 2.6), Clinical Overview (Module 2.5), Clinical Summary (Module 2.7)
- Review and compilation of Non-Clinical and Clinical literature references (Module 2, 4 and 5)
- Review and compilation of technical CMC, Non-Clinical, Clinical documents for Module 3, 4 and 5
- Assistance in responding to questions from regulatory agencies during submission review
- New Drug Application (NDA), Biologics License Application (BLA) and Marketing Authorisation Application (MAA) compilation, e-publishing and submission of the Common Technical Document (CTD) Modules 1 through 5, as per the ICH eCTD specifications to the regulatory agencies
- Assistance in preparation of region-specific documents for Module 1 including product information
- Review of Quality Overall Summary (Module 2.3), Non-Clinical Overview (Module 2.4), Non-Clinical Written and Tabulated Summaries (Module 2.6), Clinical Overview (Module 2.5), Clinical Summary (Module 2.7)
- Review and compilation of Non-Clinical and Clinical literature references (Module 2, 4 and 5)
- Review and compilation of technical CMC, Non-Clinical, Clinical documents for Module 3, 4 and 5
- Assistance in responding to questions from regulatory agencies during submission review
Reporting and Submission Maintenance
- SAE reports submission
- DSUR/PSUR reports submission
- Global submission annual reports
- Submission amendments, variations and supplements
- Investigator Brochures (IB) development and annual updates
- Orphan Designation annual and maintenance reports
- Pediatric Investigation Plans (PIP)/ Pediatric Study Plans (PSP) development, modifications and compliance checks
- EMA authorized representative for non-EU established sponsors
- US agent/ authorized representative for non-US established sponsors
Regulatory Agency Interactions At A Glance:
- Strategy and planning
- Meeting requests and briefing documents
- Meeting rehearsals and facilitation
- Meeting minutes and follow-ups
Global Regulatory Affairs accelerates the global development of drugs, biological products and medical devices, by applying our experience of working with global and local regulatory authorities, and in-depth knowledge of the dynamic regulatory landscape.
