Hagit believes in customer tailor made solutions, and will work with you to find the best solution for your company. In addition, she has working and personal relationship with other consultants in US, EU and Israel and can bring other consultants on board when experts in specific areas are also required.
Dr. Hagit Marchaim can provide your company the following regulatory services:
- Regulatory strategy for product development, pre- and post- marketing authorization
- Regulatory assessment (gap analysis) of the data and documents required for regulatory submissions
- Preparation, review and management of meeting with Health authorities, including: pre-IND/IDE, pre-submission meeting, EOP2 meeting, pre-BLA, pre-NDA or Type A/Type C meeting, SPA, Scientific Advice and Protocol Assistance meetings
- Design/Review of non-clinical pharmacology/toxicology studies
- Design/Review of Chemistry, Manufacturing & Control (CMC) plans/processes and submissions
- Management of Out Of Specifications (OOS) events
- Screening and oversight of CTOs (Contract Testing Organizations) in various activities
- Preparation and review of clinical documents: Investigator Brochure, Clinical Protocols, Clinical Reports etc.
- Regulatory preparation and submissions of:
- FDA: IND, IDE, SPA, BLA, NDA, meeting request and package, orphan drug designation, fast track, PSP, DSUR, IND amendments, post approval supplements, ANDA, Clinical evaluation for medical devices, 510-k, PMA
- EU: CTA, IMPD, MAA, orphan drug designation, scientific advice, variations
- Israel: Clinical Trial Applications, Marketing Authorization Application, Renewals
- ROW: Registration, in collaboration with local representatives.
- Training in Regulatory Affairs
In addition, Hagit has gained significant knowledge and experience in all aspects of drug development throughput the product life cycle and provides consultation on drug development.