Knowledge for Navigating Challenging Regulatory Pathways

Moving drugs and biologics from the bench into the clinic and on to market approval requires deep expertise. From traditional small molecules to advanced biologics, across the complete array of dosage forms and a wide range of therapeutic areas, we will help you navigate complex regulatory processes and advance your program into the clinic. With centralized hubs in North America, Europe, and Asia, we can handle your needs anytime, anywhere.

Solutions

Regulatory Affairs

  • Global expertise
  • Regulatory strategy and execution
  • Regulatory agency meetings, responses, and liaison services
  • Investigational applications (IND/IMPD/CTA/CTX) and amendments
  • Marketing applications for drugs and biologics (ANDA/NDA/MAA/505(b)(2)/BLA)
  • Type II drug master files (DMF)
  • Orphan indications and fast track designations

CMC Strategy, Management, and Communications

  • Drug development strategic consulting
  • Process controls, specifications, and formulation assistance
  • CMC project management
  • Writing Module 3 documents
  • CMO selection and management
  • Supply chain coordination

Medical Writing

  • Writing scientific, medical, and technical documentation for drugs, devices, and biologics, including:
    • Annual reports
    • Clinical trial applications
    • Formulary dossiers
    • Integrated clinical statistical reports (ICSRs)
    • Investigator brochure
    • Clinical evaluation reports (CERs)
    • Marketing applications
    • Protocols
    • Regulatory briefing documents
    • Risk evaluation and mitigation strategy (REMS) and risk management plans
    • Safety reports

GxP Quality Assurance

  • Supplier auditing
  • Audit-readiness preparation and assessments
  • Design quality systems, standards, SOPs, and metrics
  • Quality system remediation
  • Regulatory authority inspection support
  • Change control/management
  • Documentation review and change control
  • GxP investigations/deviation reports/CAPA system
  • Quality agreements
  • Training

Regulatory Operations

  • Support for regulatory dossier submissions around the world in both eCTD and non-eCTD formats:
    • Submitting CTA and IND applications
    • Writing, formatting, and submitting eCTDs