We can help you navigate through the complex regulations and registration processes necessary to test new drug products and bring them to market. Whether you need advice, or more in-depth assistance with document preparation, we can help. We prepare regulatory documentation such as:
- Drug master files for EU or U.S. (Type II) in CTD-format
- CMC parts for NDAs/ANDAs
- Complete or partial registration files (EU format)
- Manufacturing documentation for the IND submission, complete with updates
- Support during registration including responses to deficiency letters issued by the authorities
- EP-Certificates of Suitability (CEP)
- Support after filing, such as maintenance of the registration documentation
- Stability programs and reports
- Validation of analytical methods