Developing safe, stable and effective injectable products.
Parenteral solutions and emulsions are complex formulations both in how they release the drug into the body and how they are formulated to be effective for their intended use and remain stable over time.
Due to these products bypassing the body’s natural defenses, they must be exceptionally pure and free from contaminants, posing a challenge to pharmaceutical companies that manufacture such products.
Exova SL Pharma offers parenteral CMC product development and clinical manufacturing services that help you meet the stringent requirements and specifications enforced by the Food and Drug Administration (FDA).
These services include:
- Pre-formulation and formulation development
- Clinical batch aseptic manufacturing (Phase-1 and Phase-2)
- Analytical development and validation
- Microbiological development and validation
- Filter validation bacterial retention studies
- Sterilization and depyrogenation development and validation
- Container/closure compatibility and integrity testing
- Lab-scale and clinical batch manufacture
- Batch release and ICH stability testing
- Environmental monitoring
- Media fills
- Master batch records
- Packaging and labeling
- Technology transfer
- Development of technical and regulatory documentation
Exova SL Pharma’s facility is Good Manufacturing Practice (cGMP) compliant. Our highly knowledgeable scientists guide you through the development of stable parenteral products, from determining the degradation profile of the drug to conducting stability studies, process compatibility and scale-up. They take special care to ensure that micro-organisms and other extraneous materials are not present, safeguarding the quality and safety of your product. We provide efficient collaborative support on time and budget every time.