Regulatory and Medical Writing
ICBio Medical Writing team provides ICH GCP compliant Clinical Trial documents, accurately written documents as per standard formats, medical writing services ranging from entire drug development life cycle, and to the post-marketing reporting and commercialization writing. Our team of medical writers delivers accurate, timely, and cost-effective clinical and regulatory documents to the highest quality and scientific standards. Our medical writers are very flexible to meet your needs, using our expertise to transform your complex and diverse data into an accurate and evidence-based clinical profile of the drug concerning treatment/patient safety.Our offering includes:
- Preparation of ICH GCP compliant Clinical Trial documents (Protocol development, Informed Consent Forms, Investigator Brochures, Patient Narratives, and Clinical Study Reports).
- Labeling Documents (Patient Information Leaflets, Labelling Updates, Core Data Sheet (CDS) and Package Inserts).
- Publications (Copywriting, Copyediting, Proofreading, Journal Articles, Manuscripts, Abstracts, Posters, and Presentations).
- Disclosure documents (Protocol Registration, Results Disclosure, and Plain Language Summaries).
- Common Technical Document (CTD) for EU and US Regulatory Authorities
- Pharmacovigilance; Periodic Safety Update Reports (PSUR), Preparation and Review of Annual Safety Reports (ASRs), Development Safety Update Reports (DSUR), Periodic Adverse Drug Experience Reports (PADER).
- Medical marketing reviews and reports
- Literature reviews
- Publication planning
- Scientific manuscripts
- Safety Narratives
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