We offer regulatory consulting and assistance for FDA & IVD compliance. Our team of scientists, biostatisticians, medical writers, project managers, clinical managers, and regulatory strategy experts navigate these pathways every day. Supported by an in-house team and an integrated CLIA, GCP, and GLP-compliant clinical laboratory, data management and regulatory submission becomes a simplified process for your medical products.
Schedule a consultation with our research team to discuss your specific needs.
From concept to commercialization, or for discrete projects in between, we provide all necessary diagnostic and regulatory support to complete your project in a timely manner.
A list of the more commonly requested regulatory services follows.
- Regulatory Strategy and pathway determination
- Facilitation of activities with domestic and international regulatory authorities
- Pre-submissions, 513(g) IVD PRE-IDE, PMA, and 510(k) filings
- Technical File and Design Dossier preparation and maintenance
- Product Labeling
- Facility Registration
- Warning Letter Mitigation
- Compliance auditing and consulting
- Software documentation
- Third-party review by Accredited Persons (AP)
- On-site consulting for product development projects
Experienced in the submission of all types of domestic and international regulatory filings, we take an active approach in our communications and follow-up activities with regulatory authorities, the U.S. FDA, and international regulatory agencies to facilitate the most cost-effective result for your organization
ResearchDx also maintains licensure, accreditation, certification, and/or compliance where applicable to pertinent regulatory bodies and to local, state, and federal laws. We maintain manufacturing facilities and compliance with cGMP regulations as required by the Food and Drug Administration, 21 CFR part 820, for medical devices (Quality System (QS) Regulation/Medical Device Good Manufacturing Practices).