REGULATORY, COMPLIANCE AND TECHNICAL
Diversity - of breadth, depth, complexity, criticality, timing, staffing, funding, and more. Diversity is a great word to sum up the extraordinary universe of medical product projects. Project requirements differ - a short and simple sentence that says a mouthful. Projects may share similarities, but none are completely alike.
Your project may require a short-term triage. Or you might need the long-term immersion of a team. Maybe you're seeking one focused, experienced professional to fill a critical role, or simply the assurance of the right answer to a pivotal question that is rate-limiting the whole team. The bottom line is: Whatever the scope of your project, you need what you need.
AccuReg offers a full range of consulting and technical services, ranging from guidance and advice, to on‑site collaboration and training, to turn-key delivery. And no matter the size - on projects large or small - our S4 Compliance Process applies to everything we do. Follow the links below for more information about our core service areas:
Including Extended Quality System Plans for Warning Letter and Consent Decree Remediation (AccuReg is an FDA-recognized Consultant of Record)
Including Agency Liaison (Direct Interface with Regulatory Agencies
on Behalf of Clients)
GxP, ISO, Bioequivalence/Biosimilar, Due Diligence, Vendor/Supplier
IDEs, PMAs, 510(k)s, INDs, NDAs/ANDAs, BLAs, DMFs, CMCs and More
Quality Assurance, Validation, Part 11 Compliance, Design Control, Risk Management and More
Clinical (GCP) Auditing and BIMO Auditing, Study Design and Review, CRF Development,
Pre-IND/IDE Meetings and More