Regulatory Affairs
What We Offer
CTD/eCTD compilation & module authoring
ISE/ISS & benefit-risk assessments
Clinical/CMC documentation preparation
Gap analysis & regulatory response writing
Why It Matters
Drives timely submissions with minimal rework
Ensures persuasive, data-backed arguments
Meets evolving regulatory expectations
Enhances product credibility
Our Edge
Clinical/regulatory landscape expertise
End-to-end module planning to submission
Regional/global market strategies
What We Offer
Authoring full ICH E3-compliant CSRs for Phase I–IV clinical trials
Modular writing support for sections (efficacy, safety, statistical)
Redaction-ready and anonymization-friendly versions
Integrated Summary of Safety (ISS) and Efficacy (ISE)
Alignment with protocols, SAPs, and clinical databases
Why It Matters
Essential for regulatory submission to FDA, EMA, MHRA, and global authorities
Demonstrates data integrity and study validity
Supports NDA, BLA, MAA, and CTD dossiers
Streamlines the path to approval by anticipating agency expectations
Our Edge
Medical writers with deep regulatory and clinical trial expertise
Proven experience with multinational submissions and therapeutic areas
Close collaboration with biostats, medical monitors, and clinical teams
• Available for standalone CSR writing or full clinical document packages
What We Offer
Full CER development in alignment with EU MDR 2017/745 and MEDDEV 2.7/1 Rev. 4
Clinical evaluation plans (CEP) and literature search protocols (LSP)
Gap analysis and data appraisal (clinical, PMS, PMCF, vigilance)
Why It Matters
Mandatory for CE marking and MDR compliance in the EU
Demonstrates ongoing device safety and performance
Supports regulatory submissions and renewals
Strengthens your technical documentation
Our Edge
Writers with deep understanding of MDR, IVDR, and MEDDEV guidelines
Experience across multiple device classes and clinical domains
Seamless coordination with regulatory, RA/QA, and clinical affairs teams
Methodologically sound, traceable literature review and appraisal processes
What We Offer
Regulatory dossier writing for New Drug Applications (NDA), Biological License Applications (BLA), and Marketing Authorization Applications (MAA)
Regulatory documents for medical devices, including 510(k) submissions and technical files
Expert consultation on global regulatory strategies and requirements
Preparation of common technical documents (CTD) for global submission
Why It Matters
Ensures compliance with regulatory guidelines from the FDA, EMA, MHRA, and other global agencies
Speeds up the approval process by ensuring documentation is complete, clear, and aligned with agency expectations
Reduces the risk of rejection or delays during the submission process
Streamlines communication with regulatory bodies, saving you time and resources
Our Edge
Extensive experience with regulatory agencies and global submission requirements
Expertise in writing across clinical, non-clinical, and CMC documentation
Proven success in preparing submission-ready documents with minimal revisions
Strong collaboration with clinical, regulatory affairs, and legal teams
What We Offer
Localization and cultural adaptation for target populations
Compliance with EMA, FDA, MHRA, and local ethics requirements
Why It Matters
Empowers patients to understand and participate in their care
Supports informed consent and ethical study participation
Improves health literacy and patient satisfaction
Reduces dropouts and protocol deviations in clinical trials
Our Edge
Writers trained in health literacy, patient communication, and regulatory language
Experience across multiple therapy areas, trial phases, and product types
Support for multilingual versions and culturally adapted content
Alignment with broader medical writing, trial support, and publication strategies
Why Choose MEDSYNC
Comprehensive Expertise
Specialists across medical writing, regulatory affairs, statistical analysis, clinical research communications, and healthcare advocacy.
Therapeutic Area Specialization
Regulatory & Ethical Excellence
Full compliance with GPP4, ICH guidelines, GDPR, and regional requirements.
Global Experience, Regional Insight
Proven Track Record
350 published manuscripts, 150 advisory boards, 55 statistical projects, 50 regulatory deliverables.
Quality-First Approach
Rigorous quality control, publication standards, and measurable impact.