Consulting for Regulatory Affairs, CMC/Quality and stability studies in pharmaceutical development

3R Pharma Consulting GmbH

DobelNew on Amplifa

2008Founded

1Employees

GmbHLegal form

About 3R Pharma Consulting

3R Pharma Consulting GmbH is a consulting company founded in 2008 by Dr. Manuel Zahn, headquartered in Dobel (Baden-Württemberg). The company supports pharmaceutical manufacturers with regulatory matters in Europe, the USA and worldwide – in all phases of pharmaceutical development (pre-approval) as well as in the maintenance of approved products (post-approval). Key focus areas are Regulatory Affairs, CMC/Quality consulting, the evaluation of stability studies including statistical analysis and the preparation of stability reports, the preparation of Module 3 documents and QOS, as well as GMP audits and mock inspections at API manufacturers and manufacturers of finished dosage forms. In addition, courses, workshops and training sessions on quality aspects are offered, internally or externally and tailored to customer needs. Founder Dr. Manuel Zahn brings many years of experience from the pharmaceutical industry in Germany and Sweden as well as from worldwide Regulatory Affairs activities.

Site: Dobel
Processes: Regulatory Affairs consulting (EU, USA, worldwide), CMC / Quality consulting, Stability studies (evaluation, statistical analysis, reports), GMP audits and mock inspections (APIs and finished dosage forms), Training: courses and workshops on quality aspects, Preparation of Module 3 documents and QOS, Stability Training Courses
Materials: Regulatory Affairs, CMC / Quality, Stability Studies, GMP Audits, Training Courses and Workshops
Founded: 2008
Employees: 1
Industries: Pharmaceutical industry / drug manufacturing, Pharmaceutical development (pre-approval and post-approval), Veterinary pharmaceuticals

01
Regulatory consulting and risk assessment
02
CMC/Quality documentation (Module 3, QOS)
03
Evaluation and statistical analysis of stability data
04
GMP audits and mock inspections
05
Training courses and workshops

Services and Fields of Expertise

Regulatory Affairs

Regulatory strategies and approval documentation for Europe, the USA and worldwide.

CMC

CMC / Quality

Consulting on quality-related aspects of pharmaceutical development for fast submissions and approvals.

STAB

Stability Studies

Scientific and technical consulting, stability reports and statistical analysis of stability data.

GMP

GMP Audits

Internal inspections, pre-approval mock inspections and GMP audits at API and finished drug product manufacturers.

TRAIN

Training Courses and Workshops

Basic courses and specialized workshops on quality aspects, in-house or external.

Locations

Dobel

Headquarters / Consulting office

Industries

Pharmaceutical industry / drug manufacturingPharmaceutical development (pre-approval and post-approval)Veterinary pharmaceuticals

Additional services

Regulatory Affairs consulting (EU, USA, worldwide)CMC / Quality consultingStability studies (evaluation, statistical analysis, reports)GMP audits and mock inspections (APIs and finished dosage forms)Training: courses and workshops on quality aspectsPreparation of Module 3 documents and QOSStability Training Courses

History

2008
Foundation of 3R Pharma Consulting GmbH by Dr. Manuel Zahn.
2014
Dr. Zahn active as a speaker at conferences, including 'Stability Testing for Pharmaceuticals' in London and the GMP-BERATER Tage 2014.
2015
3R Pharma present at the Stability Conference; Dr. Zahn leads workshops and seminars in March.