Makro’s Regulatory Affairs consultants are well-versed in all aspects of the clinical trial submission process to the FDA and other regulatory authorities.
Our expertise is in:
- Providing up-to-date in the evolving regulatory requirements.
- Providing product lifecycle regulatory support for IND/CTA, NDA, sNDA, and safety filings for current and future products.
- Develop regulatory strategies for domestic and international markets, quality plans, assure GMP compliance with external manufacturers, FMEA, write and submit 510k’s, IDE’s, and develop Regulatory strategies for new indications and claims.
- Compilation and submission of Protocols, CMC Updates, Nonclinical Study Reports, and Clinical Study Reports.
- Serve as regulatory liaison with the FDA and other regulatory bodies as well as internal functional departments for new product development and changes to existing products.
- Extensive experience of regulation governing the manufacture and marketing of prescription medical devices.
- Correspondence with the FDA on pre- and post-meeting logistics, action items, etc.
- Formulation of pre-IND and pre-NDA questions to the FDA.
- Collecting reviewing and updating all national legislation related to clinical trials to ensure full compliance with all applicable requirements.
- Collaborate with project teams to produce concise and comprehensive clinical documents.
- Deliver all documentation in electronic formats, according to Sponsor standard operating procedures, report templates, and preferred writing style.
- Provide Risk management plans.
- Provide Pre-marketing and post-approval annual report.
- Support Global Clinical Trail applications
- Phase I-IV integrated clinical statistical reports( ICSR)
- Integrate pertinent information from statistical analyses into clinical study reports