Generics
  • Whether you are searching for advice on developing an ANDA or setting up manufacturing suites or performing Bioequivalence or preparing to manufacture Biosimilar products, we can help you achieve your goals within your timeline.
  • The services we provide to the Generic industry includes, Regulatory Strategy, Regulatory Operations, Clinical, Nonclinical , CMC, Compliance and Regulatory Project/Program Management consulting These services include:
  • Product Development Planning
  • Strategy for Agency Meetings
  • Due Diligence of potential candidates
  • National and International Regulatory Submission Support
  • Regulatory Submission Support (electronic and paper)
  • Submission Management
  • GLP/GCP/GMP implementation strategies
  • Nonclinical Comparability
  • Analytical Comparability
  • Chemistry and Manufacturing Strategies
  • Responses to Agency Questions
  • Review of Clinical Sections of submissions
  • Provide ongoing regulatory oversight of clinical trials
  • Pharmacology and Toxicology program review and development
  • Preparation and review of all CMC sections for regulatory submission
  • Assistance in validation activities
  • Quality Systems Assessment
  • Advertising and Promotional Compliance
  • Regulatory Agency Inspection Preparation
  • GLP/GCP/GMP Audits
  • Regulatory Product/Project Management
 
  • Contact us and find out how RegSource Consulting can help.