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Regulatory Affairs

Pharmaceutical Services

Data Management & Biostatistics

Clinical Development

Phase III B Programs

Clinical Trial Safety

Medical Affairs

Medical Writing

Quality Assurance

Pharmacovigilance & Safety Surveillance

Chemistry, Manufacturing, and Controls (CMC) / Quality Assurance

Additional Expertise

Wability’s regulatory affairs group is skilled in navigating the long process of obtaining a product registration. Our knowledgeable team works with our clients to prepare and complete global or local submissions, and interacts with regulatory agencies to expedite successful authorization. Our regulatory affairs services include:

  • Regulatory Strategies
  • NDA and Pharmaceutical Documentation
  • Clinical documents (including ISS and ISE)
  • Expert reports and summaries
  • Submission through authorization
  • Regulatory consultancy for most regulatory issues
  • Investigational drug brochures
  • Clinical trial applications (CTX/IND)
  • Clinical study reports, manuscripts, PSUR
  • GCP Compliance