Since September 2021, we at GMP C.C. specialize in supporting pharmaceutical companies towards cGMP Compliance and FDA approval.
Strong of many years of experience in the pharma and healthcare industry, we support manufacturing facilities in improving and maintaining their quality approach to manufacturing and overall compliance to CGMPs regulation.
More specifically, we accompany companies towards FDA approval by adopting a holistic approach to Pre-Approval preparation, which extends from facilities compliance assessment, FDA coaching and training, to Pre-Approval Inspection management.
We will assist in the main preparation phases prior to receiving FDA Investigators, and act as a support team for Health Authority Inspections. With the help of unique tools developed by our team, we evaluate and assess current state of compliance and propose a comprehensive remediation plan, coach and train SME and management teams for a better understanding of PAI Program, FDA Mindset and Inspection Behaviors, and lead overall organization pre and during Inspection.
FDA Readiness is an all-embracing quality objective, which GMP C.C. will support by providing:
- FDA Readiness Assessment and associated Action Plan proposal
- FDA Inspections Lead Trainer with specific training modules developed by GMP C.C.
- FDA Mock/PAI/GMP Inspection Lead
- Pre-Inspection preparation phases Lead
- Lead Investigator Escort, Inspection Coordinator, and ENG-FR/FR-ENG Interpreter
- Inspection Back Room Head and Room Coordinator for enhanced effectiveness
Company Details
Gmp C.c. Questions
Gmp C.C.'s LinkedIn profile is https://www.linkedin.com/company/gmp-c-c
Gmp C.C. has
2 employees.
View email and phone details for 2
employees at Gmp C.C..
Gmp C.C.'s industry is
Business Consulting and Services
Gmp C.C.'s top competitors are
Pennsylvania Biotechnology Center,
Hydrogen Group,
Arovella Therapeutics Asx: Ala,
Yomi Pharma,
Gxpassure,
Quality Systems Compliance Llc.
Gmp C.C.'s categories are Business Consulting and Services
Gmp C.C.'s founding year is 2021
