Medical Affairs

We offer medical affairs and pharmacovigilance expertise across the entire product lifecycle. We understand the importance of time and the value of flawless execution. Our team has substantial hands-on regulatory and medical writing knowledge gained through successful and diversified experience in large pharma, emerging biotech, CROs, and FDA.

Presenting your material in its strongest, most persuasive case

Because our highly qualified Sristek medical writers and science writers bring deep understanding of the science and technology behind current initiatives, many clients have come to trust in the excellence and timeliness of our work—we're sure you will, as well.

Medical writing services designed to expedite approval

Variations in the quality of medical writing can mean the difference between a speedy drug submission and approval, and costly delays. Our highly experienced communications specialists, half of whom hold a Ph.D. or M.D., deliver full-service medical writing and editing of regulatory documents with a track record for getting it right the first time.

Supported by our sophisticated IT infrastructure and observing step-by-step quality assurance protocols from planning through final e-CTD/Documentation, our documents will meet regulatory agency specifications—i.e., protocols and PILs (ICH-E6) and CSRs (ICH-E3).

Regulatory Documents

  • INDs, NDAs, BLAs, CTDs
  • IND annual reports
  • Protocols and protocol amendments
  • PILs/ICFs
  • IBs
  • CSRs (full, abbreviated, and synoptic reports)
  • Subject narratives
  • Study narratives
  • Clinical trial registry synopses

Publications Services

  • Medical publication writing
    • Primary manuscripts
    • Oral presentations
    • Abstracts/posters
    • Review manuscripts
  • Journal submission assistance
  • Medical direction
  • Editorial review
  • Fact checking
  • Publication plan development
  • Graphics support