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7: Regulatory Submissions

& Responses


cGxP has successful direct hands-on experience with CDER, CBER, CDRH and international regulatory agencies.

  • CE Marking

  • ISO Certification

  • 510K, PMA, BLA, IDE, NDA, ANDA

  • Consent Decrees, Warning Letters, Deficiency Letters

  • cGxP excels in devising regulatory strategies with many warning letters, consent decrees, 483 responses, and deficiency responses.

Adequate Worldwide Regulatory Affairs takes on substantial importance in terms of product approvals with a host of regulatory agencies. The approval process, whether for a 510(k), BLA, or NDA, requires putting together applications that address the agencies' concerns so that approvals are as expeditious as possible. 

cGxP bridges the many disciplines required to expedite complete product development and approval.  cGxP can provide expertise in all facets of worldwide regulatory compliance.  cGxP works with your company to develop practical strategic regulatory plans.

  • Preclinical, Phase I 

  • Phase II/ III clinical pharmacokinetic and pharmacodynamic programs

  • Global Regulatory Submissions and Registrations

  • Investigation New Drug Applications (IND)

  • Investigational Device Exemptions (IDE)

  • Premarket Notifications [510(k)]

  • Premarket Approval Applications (PMA)

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  • Product Development Protocols (PDP)

  • New Drug Applications (NDA)

  • Amend mended New Drug application (ANDA)

  • Product License Applications (PLA)

  • Biologic License Applications (BLA)

  • MAA

  • Postmarket Surveillance Protocols

  • Deficiency Analysis

  • Importation licenses/export permits

  • ISO and CE Marking

  • Expert Reports, ISS, ISE, CMC

  • Registration and Listing Forms

  • Preparation/review of informed consents, investigator brochures, and clinical protocols.

  • IRB/Ethics committee approval assistance

  • Clinical study analysis plan

  • Post Approval Compliance Issues

  • Regulatory review packages

  • Regulatory Gap Analyses and Inspections

  • Audits of manufacturing and QC laboratory facilities

  • Mock inspections in preparation for Pre-Approval and Statutory FDA Inspections

  • Comparison of approved market authorization commitments to actual manufacturing practices

  • FDA 483/Audit Responses

  • Warning letter responses and corrective action development

  • 3'rd Party Certification






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