Medical 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.

RAAJ GPRAC Medical Writing team provides ICH GCP compliant Clinical Trial documents, medical writing services ranging from entire drug development life cycle, and to the post-marketing reporting and commercialization writing.

With a qualified (Medical and Paramedical) team of skilled and experienced medical writing professionals from pharmaceutical and clinical research industries, We develop quality documents, performs peer review and coordinates client reviews, performs quality checks, and accomplishes the project management of various Regulatory, clinical writing activities in both Electronic Common Technical Document (eCTD) and CTD modules.

We are preferred global Regulatory writing services provider for writing, performing independent quality review, conducting thorough technical review of dossiers and identifying gaps/performing gap analysis in already prepared/compiled dossier.

  • 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).