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.
- 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