CMC Regulatory Solutions

SOLUTIONS DESIGNED TO IMPROVE YOUR DRUG DEVELOPMENT STRATEGY AND OPERATIONS

DS InPharmatics (DSI) offers expertise in Regulatory Affairs, Chemistry Manufacturing and Controls & Quality Assurance. Our consultations cover a wide range of experience, focused on quality-based manufacturing and analytical method development, validation and troubleshooting, formulation development, stability strategy and evaluation.

Our CMC solutions include preparation and review of regulatory submissions, risk-based strategies for product development, PAI readiness, oversight of Contract Services, and the design, implementation of GMP Systems. We also consult regarding a range of products including small molecules and biologics, including New Active Substances (Cell and Gene Therapy).

Our solutions

  • Product analysis, product development plans, and regulatory strategies utilizing:
    • Fast track designation
    • Breakthrough therapy designation
    • Accelerated approval pathway
    • Priority review designation
  • Consultation for expedited program designation
    • Serious condition assessment
    • Available therapy assessment
    • Unmet medical need assessment
  • Regulatory document preparation
  • Liaison with US FDA
  • Regulatory agency meeting preparation (including the meeting request, planning, information package, minutes, and follow-up
  • Selection, qualification, and oversight of product development contractors
  • Consultation on and development of a rapid manufacturing development program to accommodate theaccelerated pace of the clinical program
  • Assessment of the benefit-risk regarding less chemistry, manufacturing, and controls (CMC) information versus patient benefit
  • Management of a commercial manufacturing program
  • Audits to ensure clinical and manufacturing facilities inspection readiness
  • Consultation on the proposed labeling and post-marketing requirements


HOW WE HELP

  • We have over a decade of experience in CMC and regulatory consulting and regulatory submissions.
  • Experience in all major therapeutic areas and all classes of pharmaceutical products, with more than 30 product approvals, including pharmaceutical, biologic, generic, combination, and veterinary products
  • We have a track record of successful interactions with global regulatory agencies.
  • We prepare dossiers (leveraging application preparation strategies to allow significant parts to easily support marketing application submissions in more than one ICH region).
  • Our consultants utilize proprietary content templates compliant with ICH and FDA regulatory requirements and technical expectations.
  • A commitment to quality, efficiency, and our clients’ needs
  • The leveraged resources of a large network