GMP Advice is an independent service company that specializes in consulting and implementing GMP and EHS requirements in the life sciences industry.
GMP Advice supports pharmaceutical and biotech companies in all questions regarding compliance with legal standards and regulations, in particular good manufacturing practices (GMP), but also environment, health and occupational safety (EHS)
GMP Advice understands complex situations and tasks, develops well-founded and pragmatic solutions, supports customers in implementation and gets involved
… with expertise, empathy and enthusiasm.
„30 years of professional experience in the pharmaceutical industry, including 20+ years in management.“
Special focuses
📌 Interim management
📌 Authority management (incl. inspections – FDA, EDQM, PMDA, kFDA, local surveillance authority)
📌 External audits (ca. 100 performed)
📌 Supplier management
📌 Validation, qualification
📌 Cleaning validation
📌 Raw material testing
📌 Employee qualification, training, elearning
📌 CMO management, quality agreements
📌 Deviations
📌 Change control
📌 CAPAs
📌 Quality risk management
📌 Management reviews, PQR
📌 Internal audits
📌 Environment, health and occupational safety
Company Details
- Founded
- 2024
- Industry
- Operations Consulting
- NAICS
-
Process, Physical Distribution, and Logistics Consulting Services
- Website
- http://www.gmp-advice.de
- Keywords
- GMP-Compliance, Interim management, Inspection readiness support, External audits, Supplier management, CMO management, Quality risk management, Employee qualification, eLearning, Environment, health and occupational safety, Management reviews, PQR, Validation, qualification, Cleaning validation, Internal audits, GMP for manufacturing/testing active ingredients for clinical trials, Introduction, review and support of quality systems, Issuance of site master files and GxP quality manuals, Regulatory, Operational Excellence, Quality Oversight, Product Quality Review, Import of a protected plant or animal species under the CITES agreement.
Gmp Advice Questions
Gmp Advice's website is http://www.gmp-advice.de
Gmp Advice's LinkedIn profile is https://www.linkedin.com/company/gmp-%CE%B1dvice
Gmp Advice's industry is
Operations Consulting
Gmp Advice's top competitors are
Biotest Ag,
Phact - Pharmaceutical Advice, Compliance & Training,
Gmptraining.com, Inc.,
Crambridge.
Gmp Advice's categories are Operations Consulting
Gmp Advice's founding year is 2024
