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3R PHARMA CONSULTING

Regulatory and Drug Development Advisory Service

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3R PHARMA CONSULTING

3R PHARMA CONSULTING provides cost-effective, timely chemistry, manufacturing, and control (CMC) solutions, registration filings and pharmaceutical development strategies worldwide, including Europe and the US.

The company also offers regulatory advice and services covering quality-related aspects of pharmaceutical development.

3R PHARMA CONSULTING strives for fast submissions and approvals of applications.
manuel kahn

GMP audits/mock inspections

3R PHARMA CONSULTING conducts internal inspections, pre-approval mock inspections, and good manufacturing practice (GMP) audits for active pharmaceutical ingredients (API) manufacturers and producers of finished dosage forms.

Evaluation of stability studies

3R PHARMA CONSULTING provides clients with scientific and technical advice, as well as stability reports and summaries. These include statistical analysis of stability data.

Courses and workshops on quality aspects

3R PHARMA CONSULTING offers basic introductory courses and specialised workshops and training courses, which are customised to meet clients’ requirements.

Courses can either be organised in-house or externally.

About 3R PHARMA CONSULTING

Manuel Zahn is the founder and managing director of 3R PHARMA CONSULTING. He has more than 29 years of experience in the pharmaceutical industry in Germany and Sweden, as well as 25 years’ experience in regulatory affairs worldwide. For more information, please make an enquiry using the form on this page.

Previous events and seminars

On 12 February 2014, Dr Zahn hosted an evening seminar at the Veterinary Medicine: From Vision to Product conference. The seminar was titled ‘Stability by Design for Veterinary Medicines’. On the final day of the three-day conference, he delivered the ‘Practical Advice on Developing a Stability Protocol for the Global Market’ presentation.

Dr. Zahn also made an appearance at the ‘Stability Testing for Pharmaceuticals’ conference in Barbican, London.

On 17 March 2014, he participated as a speaker at the pre-conference workshop ‘Practically Managing Temperature Excursions and Using Stability Data to Support Shelf-Life during Shipping and Transport’. This provided practical advice on managing temperature excursions and effectively using stability data to support shelf-life during shipping and transport.

Contact:

3R Pharma Consulting GmbH
Wildbader Str. 3
75335 Dobel
Germany

Phone: +49 708 352 76870
Email: manuel.zahn@3rpc.com
Website: www.3rpc.com

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3R Pharma Consulting Services

3R PHARMA CONSULTING reviews 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. The company generates regulatory documents such as: Common technical document (CTD) Module 3 Quality overall summaries for CTD Module 2 Summaries for…

Advice on Regulatory Issues

3R PHARMA CONSULTING helps customers reach their goals in all phases of pharmaceutical development pre-approval and maintenance of marketed products post-approval. The company's extensive experience and knowledge in regulatory sciences, chemistry, and manufacturing and control (CMC) can be used to effectively reduce the risk of failure or delay. Professional risk assessment plays a significant role…

Courses and Workshops on Quality Aspects

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 and specialised workshops that are customised to meet customer requirements. The courses can either be organised in-house or externally. Available…

Evaluation of Stability Studies

Stability testing is a vital component of the development process in pharmaceuticals. 3R PHARMA CONSULTING provides scientific/technical advice and sustainable solutions based on long-term experience and expertise. The company offers: Strategic advice concerning a science-based design of stability studies meeting regulatory requirements, in particular, ICH guidelines Q1A(R2), B, D, and E Development of cost-effective stability…

Quality Aspects

3R PHARMA CONSULTING understands that successful pharmaceutical development begins with well-designed experiments (DoE), and thorough strategic planning.

Alongside state-of-the-art technology, 3R PHARMA CONSULTING's knowledge and experience allows manufacturers to predict production performance and quality, as opposed to controlling them on the finished product. The company provides regulatory advice and services covering quality-related aspects of pharmaceutical development aiming for fast submissions and approvals. 3R PHARMA CONSULTING's quality aspect services include: Strategic and scientific/technical…

Strategy and Procedures

To achieve registration success, deployment of the correct strategy for filing in each region/country is crucial. In Europe, the choice of the correct submission procedure (such as orphan drug, centralised, mutual recognition or decentralised procedure) is a critical element. To avoid delays in approval and marketing, the choice of reference member state and concerned member…
Quick Contact 3R PHARMA CONSULTING
Quick Contact 3R PHARMA CONSULTING
Quick Contact 3R PHARMA CONSULTING


Quick Contact 3R PHARMA CONSULTING
Quick Contact 3R PHARMA CONSULTING
Quick Contact 3R PHARMA CONSULTING


Contact 3R PHARMA CONSULTING

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