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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3R Pharma Consulting GmbH
Manuel Zahn
Wildb●●●●●tr. 3
Do●●el , 75335
DE
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3R Pharma Consulting GmbH
Manuel Zahn
Wildb●●●●●tr. 3
Do●●el , 75335
DE
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Neue Medien Muennich GmbH
Werner Kaltofen
Haup●●●●. 68
Frie●●●●dorf , 02742
DE
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Neue Medien Muennich GmbH
Werner Kaltofen
Haup●●●●. 68
Frie●●●●dorf , 02742
DE
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Regulatory Affairs - 3R Pharma Consulting - reducing regulatory risk | 3rpc.com Reviews
https://3rpc.com
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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Strategy / Procedures - 3R Pharma Consulting - reducing regulatory risk
http://www.3rpc.com/index.php/strategy-procedures.html
IMPORTANT KEY TO SUCCESS. Deployment of the correct strategy for filing in each region or country is vital for registration success. In Europe the choice of the correct submission procedure (Orphan Drug, Centralised, Mutual Recognition, Decentralised Procedure) is a critical element in this. For the Mutual Recognition and Decentralised Procedures the choice of Reference Member State and Concerned Member States is key to avoiding delays in approval and marketing.
Stability - 3R Pharma Consulting - reducing regulatory risk
http://www.3rpc.com/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;.
Quality - 3R Pharma Consulting - reducing regulatory risk
http://www.3rpc.com/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
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2008 - 2016 3R Pharma Consulting - reducing regulatory risk.
Expertise - 3R Pharma Consulting - reducing regulatory risk
http://www.3rpc.com/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.
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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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