Medical Regulatory Writing

Regulatory Writing Services

Jeevan offer regulatory and medical writing services throughout the lifecycle of your product, from pre-clinical development to marketing authorization and product maintenance phase. Our expert team provides you all the support in preparation and review of documents for regulatory submissions and clinical trials. Our writers have the agility, experience and ability to work across a wide range of document types and therapeutic areas.

Regulatory Writing
  • CSRs, clinical trial products and protocol amendaments
  • IBs, ICDs and ICFs
  • Patient Information Sheet and CRF
  • Research proposals
  • Package Inserts ( Prescribing Information ) & patient Information Leaflets
  • Short Summary of Manuscripts
  • Slide Set
Regulatory Submission Documents
  • CTD Modules
  • Clinical Overviews
  • Non Clinical Overviews & Summaries
  • Module 4 : Non clinical study reports
  • Expert Reports
  • Safety & efficacy summaries
Aggregate Safety Reports
  • PSURs and PBRERs
  • DSURs and PADERs
  • Annual safety reports ( ASR )s; policy papers
  • Bridging reports
  • Resik Evalutation and Mitigation Strategies (REMS)
  • Risk management planes (RMPs)
Medical Education
  • CME Programs
  • Slide decs
  • E-learning Modules
  • Patient education material
  • Newsletters
  • Magazine Articles

Jeevan Scientific can support all the documentation activities from pre-clinical to marketing, also on-going sustainment