Quality is value
that pays off!
Services
Business Consulting
Establishing a registered pharmaceutical company in Europe is a fundamental requirement for trading medicines and pharmaceutical substances within the European Union. Drawing on long experience, Pfleging Pharma Consulting can provide for instance the following services:
- Application for a wholesale distribution license in accordance with § 52a AMG (German Medicinal Products Act)
- Application for a manufacturing license in accordance with § 13 AMG
- Application for a medical Cannabis license in accordance with § 4 MedCanG
- Development, implementation, and enhancement of efficient quality management systems
- Personnel support, optimization of quality management processes or employee training regarding complex regulatory requirements and laws governing manufacturing and distribution of medicines in Europe.
Personnel Support
Pfleging Pharma Consulting offers personnel support for various essential regulatory roles required within a registered pharmaceutical company.
Whether you need an expert on a short-term or permanent basis, necessary expertise for the following positions can be provided:
- Qualified Person according to §14 AMG for the manufacture and quality control of pharmaceuticals
- Responsible Person for Wholesale according to §52a AMG, with specific knowledge and practical experience in pharmaceutical wholesale
- Responsible Person for Narcotics, §6 BtMG (Narcotics Act), to ensure compliance with narcotics regulations
- Responsible Person for Medical Cannabis, §7 MedCanG, overseeing the cultivation, production, and distribution of medical cannabis
Supplier Qualification and Audits
Supplier and service provider qualifications, inspections, and audits are becoming increasingly essential in a complex supply chain. Conducting all required review activities for external partners is a challenging task.
If you need an independent expert or someone to handle these tasks on your behalf, Pfleging Pharma Consulting can conduct audits of production sites, service providers, and quality systems, verifying GMP or GDP compliance of locations and organizations.
Your organization for anticipated or announced regulatory inspections can also be prepared, ensuring you are “fit for inspection.”
Professional Network
My professional network includes numerous experts with a range of specialties. Pfleging Pharma Consulting can connect you with services in the following areas:
- Qualified Persons
- Laboratories for release analytics
- Brand development and marketing presence
- Packaging design
Competent and reliable services for pharmaceutical quality assurance!
I have been working with Stefanie for years and I really appreciate her reliability and competence as well as her pragmatic, but always regulation-compliant way of working!
Thanks to the support of Dr. Pfleging, we were able to successfully complete the authority inspection and received the manufacturing license in early 2024!
Dr. Pfleging's comprehensive knowledge of legal regulations ensured that even the most demanding projects were completed smoothly and successfully.
About us
Pfleging Pharma Consulting
Pfleging Pharma Consulting is a specialized consultancy in Quality Management and Regulatory Affairs, with extensive experience in the pharmaceutical and healthcare sectors in Germany, the Netherlands, and Sweden.
Dr. Stefanie Pfleging is an expert in Quality Management, bringing over 20 years of professional experience across large corporations, medium-sized businesses, and startups. Her comprehensive expertise spans pharmaceutical product development, the production of sterile, chemical, and herbal medicines, pharmaceutical distribution in Germany, development and enhancement of quality management systems, as well as audits and regulatory inspections.
Our References
Contact
I look forward to hearing from you!
Phone: +49 (0) 172 5231 465
Email: stefanie@pfleging-pharma-consulting.com