Regulatory Affairs Consulting

regulatory-affairs-consulting

Service offerings for Regulatory Affairs Consulting include:

  • Strategic planning
  • Project Management
  • US Regulatory submissions to FDA (export approvals, pre-IDEs, IDEs, 510(k)s and PMAs for all classes of medical devices)
  • FDA meetings (introductions of company and device, regulatory & clinical strategies, test plans)
  • ISO Certification and CE Marking (OUS Regulatory submissions include  Technical Files, Design Dossiers, Clinical Evaluation Reports)
  • Notified Body meetings (interviews/hiring/contracts)
  • Regulatory input on test requirements/plans, external standards, essential requirements, predicate device comparisons
  • Internal audits, including GLP animal lab audits
  • Mock FDA and Notified Body Audits
  • On-site Regulatory support during FDA and Notified Body inspections
  • Management of product recalls, safety alerts, market withdrawals
  • Decision making on reportable changes to regulatory agencies
  • Daily operational regulatory guidance and support (Acting Regulatory VP role for companies)
  • Animal study design and scribe during studies
  • Regulatory representative in due diligence discussions for acquisitions and mergers
  • Design, Development and Implementation of Quality Management System (Quality System Regulation and ISO 13485)
  • Development, implementation and maintenance of Document Control Systems
  • ISO Certification and CE Marking
  • Quality System training
  • Internal audits and audit program implementation
  • Design History Files
  • Management Representative
  • Notified Body and FDA Liaison
  • Facility Registration and Device Listing
  • Review of labeling and advertising materials

Get started today by contacting Innoventz.

Call us at (626) 796-3376, email us at info@innoventz.com , or use the Request Information form.

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13 September 2011

Bringing back new data management standards and processes from SCDM!

12 September 2011

Quyen and Mandy from Innoventz are attending the SCDM conference in Baltimore this week!