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Pharmaceutical Consulting Firm - Aseptic Processing Experts
Pharmaceutical Consulting Firm - Aseptic Processing Experts
AXYS-NETWORK - Contact us: +33 5 47 51 81 68

FDA - Expertise & Support

Current status assessment 

Compliance

Regulatory support
We assist you to secure your compliance with our Process & Regulatory Affairs Experts

The FDA (Food and Drug Administration), the health authority responsible for approving new drugs and new manufacturing sites, has a process for conducting pre-approval inspection (PAI) investigations like no other agency in its methodology. They have not delegated this responsibility to other agencies through mutual recognition programs.

They carry out numerous inspections in the workshop, observe the technicians performing their work, explore the quality systems to ensure that the quality systems are effective in guaranteeing product quality and look for any inconsistencies in the data and reports.

Their inspection is motivated by the examination of the quality systems, their processes, a perfect knowledge of the product, its process and the demonstration of its robustness.

SUPPORT FOR YOUR PAI & FDA INSPECTIONS - GAP ASSESSMENT -TRAINING

Our Missions

  1. Assessment against the FDA benchmark. Approximately 5 days on site. Deliverables: Deviations-Rating and Action Plan
  2. Support for the implementation of the action plan to achieve compliance
  3. Support for PAI and FDA inspections

Our Service

Using FDA compliance program checklists, we diagnose the adequacy of your quality systems against FDA expectations. The in-depth verification (approximately 1,000 points examined) will provide:
• the risk level of the company,
• areas where urgent correction is necessary,
• an action plan for the compliance of all systems.

We then review with team leaders the progress of building compliance, provide KPIs for advancement and management review, and help you prepare for the inspection by organizing documentation. backroom versus checklist allowing quick and secure response to investigator questions.
We recommend that you begin the compliance program at least one year before the scheduled FDA inspection date.

Avantages

  • Implementation of missions by experts with extensive experience and knowledge of the FDA (CBER & CDER)
  • Knowledge and experience of FDA operations and culture
  •  Already existing relationships

Other services 

Take advantage of experienced experts and benefit from their experience

Annexe 1
Inspections
Audits
Non Compliance