Address: Wildbader Str. 3, 75335 Dobel, Germany
Tel: +49 (0) 7083 527 6870
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3R Pharma Consulting GmbH

3R PHARMA CONSULTING supports pharma companies in achieving their goals in all phases of pharmaceutical development (pre-approval) as well as maintenance of marketed products (post-approval). We have gained extensive experience and competence in Regulatory Sciences, Chemistry, Manufacturing and Control (CMC) / Quality to allow us to effectively reduce the risk of failure or delay.

We provide regulatory advice for pharmaceutical development with the objective of fast submission and approvals.

3R PHARMA CONSULTING was founded by Dr. Manuel Zahn who offers expertise in the area of GMP, Regulatory CMC / Quality and stability testing of pharmaceutical products. Dr. Manuel Zahn has 29 years of experience in the pharmaceutical industry including 25 years of international experience in Regulatory Affairs.

Regulatory consulting
  • Consulting on national or European scientific advice;
  • Assistance with arranging scientific advice meetings with national agencies;
  • Consulting on an appropriate regulatory strategy for filings.
Gap analysis

Review of and comments on draft documents and dossiers with regard to a planned submission of a regulatory application, listing the major gaps that should be closed prior to the filing.

Generation of regulatory documents
  • CTD Module 3 documents
  • Quality Overall Summary (CTD Module 2)
  • Summaries for scientific advice meetings
  • IMPD
Statistical analysis of stability data

Statistical analysis of stability data generated on the active substance (API) or drug product, e.g. to support a shelf-life claimed based on short-term data. 3R Pharma Consulting is applying MATLAB (from MathWorks) for statistical calculation.

GMP Audits

Since 2009, Dr. Manuel Zahn, Founder and Managing Director of 3R Pharma Consulting, is a certified API Auditor. The Active Pharmaceutical Ingredients Committee (APIC), a sector group of cefic, the European Chemical Industry Council, recently extended the "APIC Certified Auditor" certification to September 2015.

The following GMP Audits are offered:
  • GMP Audit of API manufacturers (ICH Q7);
  • GMP Audits of manufacturers of medicinal products, GMP Audits of contract labs;
  • Audits of wholesalers and distributors (GDP);
  • Mock Inspections;
  • GMP advice and training;
  • CAPA investigations.
Training courses

Basic introductory courses and specialised in-house training courses or workshops tailored to the need of the customer:

  • Courses on chemistry, manufacturing and control (CMC) topics in pharmaceutical development;
  • Courses on Stability Testing including design of cost-effective stability protocols and statistical analysis of stability data;
  • Courses on the Common Technical Document (CTD) Module 3 - Quality (ICH Guideline M4-Q);
  • Courses on Quality by Design (QbD), Real Time Release (RTR), Design Space, Fisher`s Design of Experiments (DoE).
Contact

To learn more about 3R PHARMA CONSULTING's services and capabilities and how they can assist your business, please contact 3R PHARMA CONSULTING directly.



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