Premier Consulting offers a full range of regulatory support services, from product concept to submissions to regulatory interactions. Our consultants can extend the reach of your in-house regulatory team or handle it all as your regulatory department — preparing and reviewing documents for submission to regulators, helping to attain expedited development designations, and providing strategic regulatory guidance in preparation for submissions and meetings with global health authorities.
We thoroughly analyze the issues associated with your unique program and assess the regulatory environment, ensuring that you will approach regulators with confidence — minimizing risk and negotiating from a position of knowledge and strength.
Regulatory consulting services include:
- Preparation, submission, and support of pre-investigational new drug (pre-IND) meetings
- IND, NDA, and ANDA preparation, submission, and maintenance
- Assessment, strategy, and planning services, including gap analysis, risk assessment, and target product profile development
- eCTD submissions
- Requests for expedited designations
- Request, preparation, and submission for orphan drug designation, rare pediatric disease designation, and qualified infectious disease product designation
- EOP1, EOP2, pre-NDA, and advisory committee preparation and meetings
- Type A, B and C meeting requests
- Special protocol assessments
- Pediatric Study Plans (iPSPs) and Pediatric Investigation Plans (PIPs)
- Investigational Medicinal Product Dossiers (IMPD) and other international regulatory documents
- Regulatory operations
- Medical writing
- Safety and post-marketing reporting and support
MedTech-specific services include:
- Ad-hoc regulatory guidance through the product development lifecycle from investigational stages to market approval to post-market support
- High-level gap analysis of technical, regulatory and quality system documentation based on regulatory requirements
- Preparation, application and submission of FDA pre-submissions/submissions, including premarket notification 510(k), de novo classification request, premarket approval (PMA) and investigational device exemption (IDE)
- Preparation, application and submission of EU notified body/UK approved body technical files/design dossiers submissions
- Representative services, including US FDA agent, EU authorized representative, and UK responsible person
- Ad-hoc quality management system guidance and support from concept to market entry and beyond
