Regulatory Affairs
Finding the optimal regulatory pathway
Medicinal product development requires input and approval from regulatory authorities from early clinical phases up to market authorization and thereafter. During the different phases of development, critical issues may arise that need input from regulatory authorities. Practical 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 development program. Kinesis Pharma can help with all the regulatory aspects of the development process. A dedicated team of regulatory affairs consultants can guide sponsors through the regulatory process and can provide the required submission documents at any stage of development.
Our track record in Regulatory Affairs covers over 20 different therapeutic areas. Your company can rely on our expertise and high quality standards for any type of application, whether your compound is chemically synthesized, a biological or biotechnological product or a traditional herbal medicinal product (THMP).
For all steps in the regulatory process, we check for the most recent formats and guidance provided by ICH, EMA, FDA or national authorities. We are committed to your timelines for submission.
"Dedicated to making your submission a success"
Contact details
Patricia Baede M.Sc., |
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Key achievements
• Strategic regulatory input to various product development programs and due diligence processes, assessed as valuable by sponsors
• Successful coordination of national and EMA scientific advice meetings and hearings
• Successful coordination of FDA (pre) IND meetings and submissions
• Responsible for preparation and submission of orphan drug status requests
• Writing of numerous overviews and summaries
• Full dossier submission in eCTD format