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Regulatory Affairs

  • Assess, draft and submit regulatory applications or submissions for food, dietary supplements, pre-IDE, IDE, 510(k), 513(g), PMA, NDA, ANDA, RFD, Petition, CE marking, etc.
  • Guidance on how to write and format a pre-IDE, IDE, 510(k), PMA, NDA, ANDA, RFD, Petition, or CE marking in a succinct and comprehensive manner.
  • Draft and respond to 483s and FDA warning letters to effectively close out the compliance issues.
  • Represent you before regulatory agencies (e.g., US FDA).
  • Communicate with global regulatory agencies
  • Guidance on labeling and advertising (prescription and non-prescription (OTC) drugs, medical devices including IVDs, dietary supplements, and prescription food)
  • Guidance on reimbursement, registration and listing

Quality and Clinical Affairs

  •  Organizational assessment for statutory and regulatory compliance to the FD&C Act and FDA regulations.
  • Training on how to achieve and maintain compliance to FDA regulations for medical devices and drugs.
  • Mock auditing for compliance to 21 CFR Parts 210-211, 21 CFR Part 820, ISO 13485 and ISO 9001.
  • Help to establish quality system management (21 CFR Part 820), ISO 9001 and ISO 13485
  • Help to developing validation protocols for methods and processes
  • Help to establish Good Laboratory Practices (GLP)
  • Help to establish Good Clinical Practices (GCP)
  • Help to prepare for BIMO inspection
  • Draft clinical protocols
  • Help to write SOPs

Global Regulatory Compliance

  • Help to implement an adverse event reporting system in US, EU and Canada
  • Help to implement ISO 13485 compliant with EU and Health Canada
  • Help to implement ISO 9001, and ISO 14971
  • Help to implement AIMDD, MDD and IVDD

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