Medical Writing Services
Medical writing is a pivotal element in the realm of pharmaceuticals, playing an indispensable role throughout the product’s lifecycle- clinical development, regulatory submission, safety, and post-market surveillance. A number of challenges are associated with medical regulatory and safety writing that pertain to ever-evolving regulations, interpretation and analysis of complex data, effective risk communication, maintaining regulatory and safety compliance, and stringent timelines among others.
Crucial documents such as the clinical and nonclinical sections of the eCTD (Modules 2.4 to 2.7), product labels(SPC/PIL/PIs), biowaiver justifications, product reviews, pharmacoeconomic write-ups, clinical study reports, study protocols, investigator’s brochures, annual safety reports, periodic reports, are some of the documents that form the backbone of regulatory submissions, demanding a profound comprehension of regulatory guidelines, extensive experience, and an in-depth knowledge of the complexity and dynamic regulatory landscape. In essence, medical writing is the cornerstone of pharmaceutical product development, facilitating the translation of complex scientific data into precise, evidence-based documents of the highest quality and scientific rigour.
DDReg has provided its customers with global regulatory medical writing services for over 14 years to support successful filings in stringent and emerging markets. As a distinguished Safety and Regulatory Medical Writing Service provider, the dedicated medical writing team brings an extensive reservoir of experience and constitutes highly qualified medical and scientific writing professionals. DDReg stands at the forefront of excellence for drug safety and regulatory writing services; the foundation of its success lies in industry & subject-matter expertise, experience of working alongside over 120 regulatory agencies, and well-established processes that are diligently governed by Standard Operating Procedures (SOPs), checklists, and meticulous reviews to ensure that documents are compliant with international standards & guidelines, and the quality remains unwaveringly superior.
DDReg's medical writing team is exceptionally adaptable, readily embracing client-specific processes and templates to craft documents with precision. They are well-equipped to develop and review documents that are imperative for supporting clinical development, regulatory submissions, drug safety, and pharmacovigilance. The team works closely with the Regulatory Affairs and Pharmacovigilance departments according to project-specific requisites to optimize time management and ensure project completion.
The medico-regulatory and safety writing team at DDReg possesses exceptional qualifications and technical prowess, excelling in gathering pertinent information from diverse sources such as scientific literature and safety data. Their capabilities encompass drafting, compiling, and rigorously reviewing a wide array of documents. Their proficiency extends to scientific writing, non-clinical regulatory writing, crafting bioequivalence study waivers employing in-vivo, in-vitro correlation, or comparative dissolution data as well as aggregate safety reports services in pharmacovigilance. DDReg's track record boasts collaboration with prominent global organisations, including pharmaceutical companies, Contract Research Organizations (CROs), and Biotech firms, all of which rely on the team's expertise to meet stringent submission deadlines.
DDReg has solidified its reputation as a leading global medical writing service provider, boasting an impressive history of crafting a wide range of documents for submissions on a global scale. This includes submissions to stringent regulatory authorities such as the US FDA, EMA, UK MHRA, PMDA, Health Canada, as well as other authorities for emerging markets (i.e., LatAM, CIS, MENA, GCC, ASEAN, ANZ) with varying levels of regulatory oversight. Drawing from a wealth of experience spanning the pharmaceutical industry, clinical research organizations, and academia, DDReg's medical writing team undergoes rigorous scientific, editorial, and quality control reviews for all documents. They function as a subsidiary of its client’s team and are adaptable and attentive to the client’s unique needs, utilizing their expertise to transform intricate and multifaceted data into a precise, evidence-based narrative detailing the drug's clinical profile in terms of treatment and patient safety.
DDReg offers a diverse range of medical writing solutions throughout all stages of the product lifecycle:
Clinical Development Plan & Documentation:
Preparation and/or review of IB, Safety Narratives, Informed consent documents, safety summaries, and clinical overviews
Medical Rationale e.g.: FDCs, Fast track designation request, etc.
Orphan Drug Designation
Preparation and submission of Paediatric Investigation Plan
Pre-submission/ Agency Meeting support (e.g.: FDA meetings(Type A, Type B & Type C), UK MHRA Scientific meetings, PMDA meetings, etc.) - Pre-meeting packages (PMPs)/briefing packages
Preparation & review of posters, Abstracts
Quality and regulatory review of clinical study reports for global submission
Regulatory due diligence of early phase, Phase IIa/IIb, Phase III & Bioequivalence clinical protocols (e.g. FDA requirements & guidance documents)
Regulatory Filing and Submission:
Authoring, compilation as well as a review of Clinical and Non-Clinical sections (i.e., Section 2.4 to 2.7 & M4 & M5) of NDA & ANDA for global submissions
Authoring, review & update of SPC, PIL, CCDS, SPL, PI
Bio Waiver Justification, “Well Established Use” justifications for EU
Conducts critical literature review
Development/Review of Risk Management Plan(RMP)
Preparation & review of clinical & Non-clinical modules of BLA
Regulatory Query response preparation and submission
Support integrated summary reports on Efficacy and safety
Support Risk Evaluation & Mitigation Strategy (REMS)
Post Approval & Life Cycle Management:
Authoring and compilation of aggregate safety reports (PADERs, PBRERs & PSURs)
Authoring, review & compilation of post-life-cycle management (Label updates, Clinical and non-clinical documentation, etc.)
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Clinical Trial Transparency and Disclosure
Claims development for CHC & Cosmetics
Development of RMPs, RMMs, ARMMs
Patient narratives for PASS studies (ICH-E3 Section 14.3)
Pregnancy Prevention Program (PPP)
Review of protocols & CSRs for Phase IV studies.
Scientific Communication: Manuscript, Product Monographs, slide decks, posters & abstract, etc.