Medical Writing Services
Enhance Regulatory Documentation with DDReg’s Expert Medical Writing Services. Our experienced medical writing team delivers high-quality, compliant documentation that supports every stage of the product lifecycle. We offer end-to-end writing solutions, from regulatory submissions and clinical documentation to safety narratives and risk assessments—ensuring clarity, accuracy, and alignment with global standards. Deep understanding of CTD structure and regulatory expectations allows us to produce precise, submission-ready content that supports efficient reviews and successful approvals.
DISCOVER MORERegulatory Medical Writing Services
Medical writing is an indispensable requirement in the pharmaceutical and biotechnology industries. Our regulatory writing solutions support the entire product lifecycle – from clinical development and regulatory submissions to post-market surveillance and safety communications. We address the multifaceted challenges of documenting complex clinical data and navigating evolving regulatory guidelines.
DDReg’s dedicated team leverages robust processes, including standardized procedures and custom templates, to craft documents that meet global standards. Our expertise in regulatory medical writing ensures that every submission – from clinical study reports to CTD sections to Safety report– is prepared with precision, and scientific rigor.
Regulatory and Safety Writing Solutions
Our writing services are designed to deliver quality and compliance at every stage of the product lifecycle. We create essential documents such as clinical and nonclinical sections of the eCTD (Modules 2.4 to 2.7), product labels (SPC/PIL/PIs), biowaiver justifications, product reviews, and pharmacoeconomic write-ups. In addition, we develop clinical study reports, study protocols, investigator’s brochures,annual safety reports and aggregate reports (DSURs, PSURs, PBRERs, and PADERs).
With over 14 years of experience, our medical writing consulting services integrate deep subject-matter expertise and a client-focused approach. We work closely with regulatory affairs and pharmacovigilance teams to ensure that our documentation not only meets stringent global regulatory standards but also communicates risk and efficacy clearly.
Our Medical Writing Expertise
Clinical Development Plan & Documentation
- Diversity Plan
- 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)
- 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)
- Authoring and compilation DSURs
Regulatory Filing and Submission
- Preparation & review of clinical & non-clinical modules of BLA
- Pharmacoeconomic write-ups
- 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.)
- Advertisement storyboard review service
- 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.
- Website content
- Annual safety reports preparation & submission
Ready to elevate your medical writing documentation?