Navigating the Diagnostic Pathway with Ease and Efficiency
At ResearchDx, our regulatory affairs team of scientists, biostatisticians, medical writers, project managers, clinical managers and regulatory experts understand and navigate the diagnostic pathway every day. Supported by an integrated CLIA and GLP compliant clinical laboratory, the data management and regulatory submission becomes an efficient and simplified process for your IVD diagnostic.
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. If you don’t see what you need, just ask.
- Regulatory pathway exploration and strategy development
- Indications for use
- IVD PRE-IDE, PMA and 510(k) filings (and others)
- International regulatory filings
- Regulatory compliant labeling
- Expedited reviews
- Compliance auditing and consulting
- Software documentation
- Third party review by Accredited Persons (AP)
- Consulting projects
Experienced in submission of all types of 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. These include but are not limited to diagnostic pre-submission strategies, potential regulatory pathways, compliance test requirements or clarification and follow-up of all submissions under review.
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).