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Medical Writing

We provide a full range of writing services for regulatory submissions, scientific communications and medico-marketing material, across diverse therapeutic areas for all phases of product life cycles, from pre-clinical development to post-marketing literature. We ensure timely delivery of accurate, consistent and regulation-compliant documents to our Sponsors in a cost-effective and flexible manner.

We organize our operations into integrated Sponsor-centric units, to enhance Sponsor-focus, and to drive operational agility that can result in delivery with quality, speed and value.

All GVK BIO Medical Writers undergo regular training to ensure uniform adherence to regulatory standards and to have consistency across writing processes. Our Medical Writers are Drug Development scientists who have the required scientific background, regulatory knowledge and professional attitude to get embedded in the Sponsor’s study teams during clinical development process of a molecule. We write quality scientific communications that are suitable for the Sponsor’s need, be it for its scientific disclosures or regulatory submissions.

Medical Writing Services

medical writing

Key Differentiators

Expertise in Clinical Research, Discovery and Pre-clinical Research

Peer Review and Quality Check Process

At GVK BIO, each document goes through an extensive peer and management review. Before finalization, each document is reviewed by our medically qualified personnel. Document management is done under strict security measures to maintain data confidentiality. Documents are finalized only after undergoing stringent quality control checks.

 

All documents conform to ICH guidelines.

Team Expertise

  • Our team of Medical Writers (PhD, M.Pharm, MSc) have expertise in writing and developing protocols, ICDs, IBs, CSRs, patient narratives, various modules of CTD, manuscripts, periodic safety update reports for global submissions and product development rationales.
  • We also have highly educated reviewers from Medical Affairs (MD) and Bio-statistics (MSc) for scientific review.

Success Stories

  • Developed and wrote a Clinical Development Plan (CDP) with international scope for a US Sponsor (trials in US and India)
    • Sponsor was pleased with our scientific expertise
    • Also provided high level therapeutic and scientific expertise for multiple indications for their other molecules
  • Successful full service Phase III study with a completed Final Study Report, for a European Sponsor; earned other businesses as well
  • Generated study report for a Phase III study in record time helping the Sponsor get quick regulatory approval