DDReg Pharma

Medical Writing Services

The highly experienced medico-writing team have developed procedures and templates to ensure the modules of CTD’s are detail-oriented and additionally provide expertise in Bio Waiver Justifications and Well Established Use.

Clinical & Non Clinical Expert Reports

Writing Clinical and Non Clinical sections (i.e Section 2.4 to 2.7 & M4 & M5) of CTD require specialized ...

Bio Waiver Justifications

Biowaivers are essential for applicants to justify MA for maultiple strengths of Oral Solid Dosage forms (OSDs)...

Well Established Use

A procdures allowed by EMA wheres, if an active ingredient of a medicine has been used for more than 10 years...

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:
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