CMC REGULATORY 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 CMC regulatory consultants 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 regulatory 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).
- 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