pharmaceutical products, medicines, regulatory affairs, application procedures, Chemistry Manufacturing Control (CMC), Stability Testing, Quality by Design, Release (RTR), Process Analytical Technology (PAT), Quality Control, Good Manufacturing Practice (GMP), Quality Assurance, Inspection, Anti-counterfeiting, Qualified Person (QP), CTD Module 3, training, courses
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Regulatory Affairs - 3R Pharma Consulting - reducing regulatory risk | 3rpc.de Reviews
https://3rpc.de
pharmaceutical products, medicines, regulatory affairs, application procedures, Chemistry Manufacturing Control (CMC), Stability Testing, Quality by Design, Release (RTR), Process Analytical Technology (PAT), Quality Control, Good Manufacturing Practice (GMP), Quality Assurance, Inspection, Anti-counterfeiting, Qualified Person (QP), CTD Module 3, training, courses
3rpc.de
Quality - 3R Pharma Consulting - reducing regulatory risk
http://www.3rpc.de/index.php/quality.html
QUALITY COUNTS IN EVERY STAGE. Successful pharmaceutical development starts with well designed experiments (DoE) and sound strategic planning. Knowledge and experience combined with modern technology will help manufacturers to predict manufacturing performance and quality instead of controlling them on the finished product. 3R PHARMA CONSULTING provides regulatory advice and service covering Quality-related aspects of pharmaceutical development aiming at fast submissions and approvals of applications.
Sitemap - 3R Pharma Consulting - reducing regulatory risk
http://www.3rpc.de/index.php/sitemap.html
2008 - 2016 3R Pharma Consulting - reducing regulatory risk.
Expertise - 3R Pharma Consulting - reducing regulatory risk
http://www.3rpc.de/index.php/expertise.html
Dr Manuel Zahn, founder and managing director of 3R PHARMA CONSULTING, offers expertise in the area of GMP, Regulatory CMC / Quality and stability testing of pharmaceutical products. 29 years experience in the pharmaceutical industry (in Germany and Sweden). 25 years experience in Regulatory Affairs (world-wide). Qualified Person (QP) according to Directive 2001/83/EC, Art. 49 and 51. APIC Certified Auditor of API manufacturers (ICH Q7). Negotiation skills in a cross-cultural environment.
Stability - 3R Pharma Consulting - reducing regulatory risk
http://www.3rpc.de/index.php/stability.html
STABILITY LEADS TO PROGRESS. Stability is an essential quality attribute of active substances and pharmaceutical products and, therefore, stability testing is a crucial component of the development process. 3R PHARMA CONSULTING provides scientific/technical advice and sustainable solutions based on long-term experience and expertise. Strategic advice concerning a science-based design of stability studies meeting regulatory requirements, in particular ICH Guidelines Q1A(R2), B, D, and E;.
Training - 3R Pharma Consulting - reducing regulatory risk
http://www.3rpc.de/index.php/training.html
HOW TO ACHIEVE KNOW-HOW. It is essential for regulators and company experts to keep up-to-date with science and technology by receiving first-hand information direct from a practitioner who offers solutions and support. 3R PHARMA CONSULTING provides basic introductory courses as well as specialised workshops and training courses tailored to the need of the customer. The courses can either be organised in-house or externally. Courses on GMP topics like preparation of an inspection;. The science behind the...
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Regulatory Affairs - 3R Pharma Consulting - reducing regulatory risk
3R PHARMA CONSULTING provides cost-effective, timely solutions to strategic issues in European, US, and rest of world registration filings and challenges in pharmaceutical development. Professional risk assessment contributes significantly to reducing the time from identification of a lead compound to submission and regulatory approval of a pharmaceutical product of high quality and well defined performance. To discuss specific project needs. 2008 - 2015 3R Pharma Consulting - reducing regulatory risk.
Regulatory Affairs - 3R Pharma Consulting - reducing regulatory risk
3R PHARMA CONSULTING provides cost-effective, timely solutions to strategic issues in European, US, and rest of world registration filings and challenges in pharmaceutical development. Professional risk assessment contributes significantly to reducing the time from identification of a lead compound to submission and regulatory approval of a pharmaceutical product of high quality and well defined performance. To discuss specific project needs. 2008 - 2015 3R Pharma Consulting - reducing regulatory risk.
Regulatory Affairs - 3R Pharma Consulting - reducing regulatory risk
3R PHARMA CONSULTING provides cost-effective, timely solutions to strategic issues in European, US, and rest of world registration filings and challenges in pharmaceutical development. Professional risk assessment contributes significantly to reducing the time from identification of a lead compound to submission and regulatory approval of a pharmaceutical product of high quality and well defined performance. To discuss specific project needs. 2008 - 2015 3R Pharma Consulting - reducing regulatory risk.
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