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)
Whatever the project demands, AccuReg
will bring the best resources to bear
to get the
job done right.
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
Need more information?
through social media
Clinical (GCP) Auditing and BIMO Auditing, Study Design and Review, CRF Development,
Pre-IND/IDE Meetings and More