Regulatory and Clinical affairs
I can assist you in optimizing and guiding the Clinical and Regulatory advancement of your Drug by working in collaboration with your team on the aspects described below. I have brought several pharmaceutical drugs from conception, through Pre-clinical and clinical stages up to the market and am regularly involved in interactions with Regulatory Authorities and am experienced in a very wide range of activities to enable to reach this goal with your Drug.
- Strategic regulatory planning for product development seeking International Regulatory approval
- GMP audits and inspections
- Preparation and Review of clinical documents such as:
- Investigator’s Brochure
- Study Protocol
- Study reports
- IMPD documents
- CTD documents
- Assist in the preparation, organization and attend Pre-IND meetings
- Local and global scale assistance with the development of your product.
- Preparation, audit and review of regulatory documentation before submission to regulatory authorities (IND, CTA)
- Support and foster efficient collaboration with Authorities through providing proactive, customized high quality solutions.