Confidence Beyond Compliance

Medical / CMC writing services are required to support clinical trial documentation and authority applications starting during the early phases of development.

PharmaLex provides experts that ensure our clients scientific and medical communication materials are clear, concise, scientifically accurate and fully compliant with regulations, industry best practices and our clients corporate guidance. PharmaLex is a highly experienced partner to develop an integrated CMC strategy to support development goals from the very beginning. Amongst other services, regular project work includes:

  • Cell line development
  • Analytical method development – Phase I-IV protocols
  • Phase I-IV integrated clinical statistical reports (ICSR)
  • Global clinical trial applications
  • Authoring and review of CMC for IND and NDA / BLA / CTA
  • Formulary dossiers
  • Standard responses
  • Investigator brochures
  • Risk evaluation and mitigation strategy (REMS)
  • Medication guides and patient information leaflets (PILs)
  • Contact center materials
  • CMC Technical support validation, formulation and during scale-up
  • CMO selection and oversight, incl. batch release
  • Manufacturing strategy
  • CMC Quality Management
  • Pediatric investigational plans
  • Orphan drug designations
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