serving the pharmaceutical & related industries

Pharmaceutical Regulatory Assistance

Document Preparation, Filing and Managing FDA Drug Applications

  • Filing and Managing all of the Processes for FDA Drug Applications
  • Submission Planning and Preparation
  • Pharmaceutical Regulation Consulting
  • Inception to FDA Qualification Filing
  • Accurate Regulatory Submissions
  • Submission Planning and Preparation
  • Effective procedures to comply with requirements for adverse drug event (ADE) management and reporting
  • Consulting for product labeling, advertising, and promotional materials for regulatory compliance
  • Technical writing and specifications for protocols, reports, policies, and procedures
  • PTS Global Consultants has assisted US, Canadian, European Union and Asian clients in reviewing and preparing key documents for review by FDA

Expertise:

  • 510ks
  • ANDAs
  • DMFs
  • INDs
  • NADAs
  • NDAs
  • PMAs
PTS Pharmaceutical Consulting
Contact PTS Global Services