At VxP Biologics, we have extensive experience with Method Development, and Method Validation, meeting FDA, GMP, and ISO requirements. We can provide analytical method development and validation services to support your requirements from pre-clinical research through clinical development and CMC/Commercial manufacturing.
Our analytical team consists of highly skilled chemists trained in developing and validating phase/study specific methods for small and large molecules. We have developed and validated multiple proprietary, in-process and stability-indicating methods for assays of raw materials, API and other drug products.
Method Development and Validation Services
- Assay method development and validation services as per ICH/FDA/USP guidelines:
- Support in formulation development studies
- Release testing of API, finished drug products, and other devices.
- Stability testing programs
- Impurities method development and validation services as per ICH/FDA/USP guidelines:
- API / Other drug substances
- Pre – formulation / Drug – Drug / Drug – Excipient compatibility studies
- Finished drug products
- Devices containing pharmaceutically active compounds
- Stability testing programs
- Dissolution method development and validation per ICH/FDA/USP guidelines:
- Intrinsic dissolution / Solubility of API or other drug substances
- Finished drug products including modified release dosage forms
- Stability testing programs
- Cleaning validation method to determine if any residual agents or active compounds are present in equipment/facilities
- Coupon/swab recovery
- Material recovery from swab after controlled spike
Contact us today for a free consultation with the scientific team and discover how VxP can be a valuable resource and partner for your organization.