Regulatory Affairs ServicesClinquest’s Regulatory Affairs Team supports biotechnology, pharmaceutical, medical device, and medical diagnostics companies on project management, regulatory strategy and operations, technical writing, and SOP development. Regulatory Affairs Core Services:- Develop international regulatory strategic plans
- Recommend optimal national and international requirements for each stage of development
- Ensure product development plans comply with current regulations
- Develop compound-specific regulatory strategies
- Provide guidance regarding the structure and operations of client regulatory affairs department
- Provide advice and coordinate registration plans during each step of development
- Develop, write, compile, and review regulatory submissions, including IND, NDA, BLA, PMA, ANDA, CTA, IMPD, yearly updates, risk management and evaluation plans, and other supplements
- Inclusion of required data
- FDA, EMEA and ICH guidance compliance
- Understanding and fulfillment of reviewers’ requirements
- Clear, logical and evidence-based support documents
- Adherence to strict timelines
- Orphan Drug Application
- Review of CMC, preclinical toxicology, and safety pharmacology documents
- Provide regulatory support for clinical trials
- Provide full regulatory support for key Milestone regulatory meetings
- PreIND, EOP2, PreNDA, labeling, pediatric, risk management, CMC and scientific advisory meetings
- Meetings can be requested, coordinated, and attended by our staff
- Provide negotiation strategies
- Act as a U.S. Regulatory Agent for foreign companies
- Liaise closely with regulatory authorities on a regular basis
- Train and advise personnel on regulatory requirements and topics
- Manage regulatory inspections
- Support post-marketing services including annual reports, field alerts, promotional material review, and manage risk management or evaluation programs
- Prepare and coordinate eCTD submissions
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