Regulatory & Quality

Axiom Regulatory and Quality provides an understanding of industry guidelines and requirements to our clients and partners. Much like our organizational culture, we believe it is paramount to impart our knowledge to our clients and partners to reinforce the quality systems. This may begin with a forensic evaluation of previously validated facilities and processes, in addition to review procedures. Many of our previous projects have withstood the scrutiny of regulatory agencies and we have the “know how” for compliance adherence and remediation. Axiom can assist with reorganization of quality systems to ensure compliance, as well as assist with regulatory submissions, cGMp Audits, cGLP Audits and FDA warning letters.

Regulatory Submissions:

The regulatory services part of Axiom provides assistance for submission to regulatory entities throughout the world. This includes producing high level summary documents and application submittals, while maintaining dialogue with regulatory agencies during every step of the review process. Our FDA application expertise includes:

  • Investigational New Drug (IND) Application
  • Investigational Device Exemption (IDE)
  • New Drug Application (NDA)
  • Therapeutic Biologics Applications (BLA)
  • Abbreviated New Drug Application for Generics (ANDA)
  • Emergency Investigational New Drug (EIND) Applications for Antimicrobial Products
  • Over-the-Counter Drugs (OTC)
  • Premarket Approval (PMA)
  • 510(k) Process

We ensure compliance with applicable Code of Federal Regulations (CFR).

With a wide range of specialties in Active Pharmaceutical Ingredients or Drug Substance, Bulk Intermediates, OTC, Solid, and Liquid Dosage Forms, Biotechnology / Biologics, Nutraceuticals, Pharmaceuticals, Parentals, Clinical Manufacturing, Finishing / Packaging, Cosmetics, and Medical Devices, the following aspects are supported by Axiom Regulatory and Quality Audits:

Regulatory and Quality Audits:

  • Regulatory Agency Prevention Plans
  • Consent Decree Audits
  • Regulatory Agency Filing Support
  • Document Review and Preparation
  • Legal Support
  • cGMP Training Program
  • Standard Operating Procedure Program
  • cGMP, cGLP, and GxP Audits
  • FDA and EMEA compliance

Regulatory Actions:

  • Warning Letter Responses
  • Consent Decree Remediation
  • 483 Responses
  • Audit Responses

Contact us for assistance in the event of FDA warning letters or 483 issuance. See our other services for program management, project engineering, qualification & validation, and strategic sourcing.