Developing novel and generic drug products.
Chemistry, Manufacturing, and Control (CMC) activities form a crucial part of any clinical trial. Drugs can be denied marketing approval if the quality of the product and the manufacturing process fail to satisfy regulatory requirements. Ensuring that the trial is designed and developed to as near perfection as possible allows accelerating the drug development process.
Exova SL Pharma has provided full CMC development for several NDA 505-b applications as well as generic drug products (ANDAs) and our work has led directly to the successful regulatory approval and commercialization of parenterals dosage forms, ophtalmics, and topicals.
Pharmaceutical formulation development helps to enhance drug delivery performance and product stability.
Analytical development and quality control testing.
Microbiological development and quality control testing.
Parenteral product development and clinical manufacturing phase l and ll.
Topical product development and clinical manufacturing phase l and ll.
Consulting services driven to service your needs. Development and implementation of strategies and detailed plans for your business.
Our CMC product development services include:
- Pre-formulation and formulation development
- Drug/excipient/packaging compatibility
- Early stage stability studies for active drug substances and product formulations
- Clinical manufacturing (phase I and phase II)
- Media Fills
- Microbiological development and QC testing
- Stability indicating assay development, method validation, and forced degradation studies
- Full ICH stability storage and testing
- Technology transfers
Exova SL Pharma’s laboratory complies with Good Manufacturing Practice (cGMP) guidelines and is regularly inspected by the Food and Drug Administration (FDA). We commonly test to USP, NF, EP, BP, JP as well as provide other customized methods.Our experience and in-depth knowledge of the drug development and commercialization process result in the efficient and successful completion of comprehensive CMC services for both small companies, including start-ups, and large pharmaceutical organizations.