Regulatory Affairs and Consulting
Medicinal product development requires input and approval from regulatory authorities (e.g. FDA, EMA) from early clinical phases up to market authorization and thereafter. During the different phases of drug development, critical issues may arise that need input from regulatory authorities. Practical regulatory affairs issues need to be considered, such as when is the best time in the development process to consult regulatory authorities, how to formulate questions to get the answer you need and how to get approval from the regulatory agencies for the proposed drug development program. Kinesis Pharma’s regulatory affairs consultants can help with all the regulatory aspects of the drug development process. Our experienced regulatory consulting team guides sponsors through the regulatory process and provides the required submission documents at any stage of development.
Your company can rely on our expertise and high quality standards for any type of application, whether your compound is small molecule, a biological or biotechnological product or a nutraceutical or traditional herbal medicinal product (THMP).
- Strategic and Regulatory Consulting
- Communication with regulatory authorities
- Preparation of submission documents / medical writing
- Clinical Trial Applications
- CMC regulatory affairs
- Nonclinical regulatory documentation
- Medical writing
- Pharmacovigilance and QPPV
- Marketing authorization support for sponsors outside EU
"Dedicated to making your submission a success"
Carina Sonnega, M.Sc.,