Clinical & Regulatory

The ability to effectively communicate efficacy and safety is crucial to procuring regulatory approval of any drug, biologic or device. Our team members have driven submissions for top pharma therapeutics and have worked with regulatory agencies in North America and Europe.

Clinical documentation

  • Clinical development plans
  • Protocols and amendments
  • Investigator’s brochures (IBs)
  • Informed Consent Forms (paper and electronic)
  • Clinical Study Reports (CSRs) and appendix components
  • Patient narratives

Our regulatory writing service includes:

  • Briefing documents and health authority responses
  • Labeling and label reviews
  • Regulatory assessments of product modifications

Regulatory submission types for drugs and biologics

  • Investigational New Drug (IND)
  • New Drug Applications (NDAs), abbreviated and supplemental applications (ANDA/SNDA)
  • Fast Track/Orphan Drug/Breakthrough Therapy applications
  • Electronic Common Technical Document (eCTD) modules
  • Biologic Licensing Applications (BLA)
  • Risk Management Plans (RMP)
  • Changes Being Effected (CBE)
  • Drug Safety Updates (DSUR/PSUR)
  • Pre-market Approval (PMA)
  • Pediatric investigation plans (PIP)
  • Post-approval Studies (PAS)
  • Prescription to over-the-counter conversions

Regulatory submission types for devices

  • 510(k) (traditional, special and abbreviated)
  • Clinical Evaluation Reports (CER)
  • Investigational Device Exemption (IDE)
  • Medical Device Licensing Applications (MDLA)

The therapeutic areas we cover include:

Allergy and Immunology  | Cardiovascular  | Dermatology | Diabetes and Endocrinology | Gastroenterology | Hematology | Neurology | Oncology |  Pain and Inflammation | Respiratory Rheumatology | Vaccines | Virology | Women’s Health