Mandava Associates provides clients with CMC and compliance through its associates who have vast experience in this field. Our group of associates has substantial experience in taking numerous APIs and biological agents from formulation development through to NDA, and for market approval.
Mandava Associates works closely with clients to provide the necessary QA and regulatory guidance for each step of the drug development process and for market approval.
Some of the services that are offered in the CMC and compliance are:
Comprehensive CMC and regulatory strategy, advice and planning
Risk assessment and disaster recovery
Management of initial plan to delivery for optimal outcome
Clinical trial supply and technology transfer
Compliance audits for GCP, GLP and GMP
Risk management for use in GCP, GLP and GMP