Validation and Product Approvals
We offer validation services which are tailored to your needs.
We assist you in producing product quality reviews (we can offer a complete package if requested) and offer you our support when you come to renew your product approvals.
From planning and execution right through to evaluation and reporting for the validation of:
- Products
- processes
- Analytical methods
- IT-systems
- Engineering support for equipment
Regulatory Services – API
We can help you to 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
Regulatory Services – DP
The registration service is organised according to the tasks and the product ranges of the companies of the Corden Pharma Group. So the expertise in the relevant technology is also available on site for registration-related questions.
In the course of the work taken on by us, with new developments we produce all the documentation so that our clients themselves can submit the file for registration for the selected markets. On request, applications for registration can be produced and submitted via reliable service providers with whom we work.
Where products change, whether it be to meet changed requirements from the registration authorities or to improve products or to ensure that medicines are safe, we take care of all the documentation, so as to successfully implement change applications known as variations.
In addition, through our registration service we can produce the documents that are needed to retain registration in the relevant markets for the medicines produced by the companies of the Corden Pharma Group.