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Regulatory Services in South AfricaMedical Writing Services
Regulatory Medical Writing is an important component for regulatory documentation that includes non-clinical & Clinical Sections (Section 2.4 to 2.7 of CTD), 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 etc.
The medico-regulatory & safety writing team at DDReg is highly qualified and technically experienced in extracting relevant information/data from all sources (e.g., scientific literature, safety data etc.), drafting, compiling, and reviewing documents. Aside from authoring CTD modules (electronic and paper-based), clinical study reports and biowaiver justifications our team also conducts critical literature review and perform peer reviews for a variety of customers, manage projects and contribute to the quality of writing in regulatory medical documentation. Our team holds years of experience in writing bioequivalence study waivers that use in-vivo in-vitro correlation or comparative dissolution data. DDReg’s team has experience in assisting leading global organizations including but not limited to pharmaceutical companies, CROs and Biotech companies that require documents to be submitted as per the strict timelines. The team combines their extensive regulatory and drug development knowledge with our in-house IT systems to consistently ensure timely and high-quality writing outputs/submissions.
DDReg Medical Writing Expertise include:
Non- Clinical overviews (eCTD Module 2.4) and Non-clinical summaries (eCTD Module 2.6)
Clinical overviews (eCTD Module 2.5) and Clinical Summaries (eCTD Module 2.7)
Compilation of eCTD Module 4 & Module 5
SPC, PIL, PADER, RMP
Clinical Study protocol, Clinical Trial reports & Investigator’s brochure
Biowaiver justification support
Query responses for documents of U.S., EU, UK, MENA, and emerging regulatory markets
Annual reports for safety & clinicals
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