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3R Pharma Consulting

3R PHARMA CONSULTING provides cost-effective, timely solutions to registration filings and challenges in pharmaceutical development strategies across Europe, the US and the rest of world.

Advice on quality/CMC aspects of pharmaceutical development

3R PHARMA CONSULTING offers regulatory advice and services covering quality-related aspects of pharmaceutical development. 3R PHARMA CONSULTING strives for fast submissions and approvals of applications.

GMP audits/mock inspections

3R PHARMA CONSULTING conducts internal inspections, pre-approval mock inspections, as well as GMP Audits of API manufacturers and manufacturers of finished dosage forms.

Evaluation of stability studies

Clients are provided with scientific and technical advice, as well as stability reports and summaries which include statistical analysis of stability data.

Courses and workshops on quality aspects

3R PHARMA CONSULTING offers basic introductory courses, as well as specialised workshops and training courses, tailored to the needs of the customer. These courses can either be organised in-house or externally.

Dr. Manuel Zahn, Managing Director at 3R PHARMA CONSULTING

manuel kahn

Manuel Zahn is the founder and managing director of 3R PHARMA CONSULTING.

Dr. Zahn 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 click here.

Events and seminars

Successfully Handling Temperature Excursions and Using Stability Data to Support Product Shelf-Life During Transport and Shipping
Pre-Conference Workshop Tuesday 24 March 2015

Informa Annual stability Testing Conference
London 25-26 March

Evening Seminar: Ensuring Effective Change Management and Impact on Stability Programs
Wednesday 25 March 2015

Previous events and seminars

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

Dr. Zahn will be making an appearance at the ‘Stability Testing for Pharmaceuticals‘ conference in Barbican, London. On 17th March 2014, he will be participating 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 interactive workshop will provide practical advice on managing temperature excursions and effectively using stability data to support shelf-life during shipping and transport.

Dr. Zahn will be chairing the conference on the first day of the conference on 18th March 2014, where he will be delivering a presentation titled, ‘Understanding and practically conducting stability studies for countries in climatic zones III, IVa and IVb’.

On the same day, he will also be contributing to the interactive round table discussion, ‘Sharing experiences and challenges with conducting stability testing for the emerging markets’.

Contact details:
3R Pharma Consulting GmbH

Wildbader Str. 3
75335 Dobel
Germany
Phone: +49-(0)7083-527 6870
Email: manuel.zahn@3rpc.com
Website: www.3rpc.com
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3R Pharma Consulting Services

Gap AnalysisReview 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 documentsCTD Module 3 documentsQuality Overall Summary (for CTD Module 2)Summaries for scientific advice meetingsGMP AuditsGMP Audit of API manufacturers (ICH Q7)GMP…

Advice on Regulatory Issues

3R PHARMA CONSULTING helps customers reach their goals in all phases of pharmaceutical development (pre-approval), as well as maintenance of marketed products (post-approval).

Our extensive experience and knowledge in regulatory sciences, chemistry, and manufacturing and control (CMC)/quality, can be used to effectively reduce the risk of failure or delay.Professional risk assessment plays a significant role in reducing the time from identification of a lead compound to submission, as well as the regulatory approval of a pharmaceutical product of…

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, 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, conferences and workshopsCourses on chemistry, manufacturing and control (CMC) topics in pharmaceutical development for regulatory people at health authorities and pharmaceutical companiesCourses on stability…

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.What 3R PHARMA CONSULTING can offer youStrategic advice concerning a science-based design of stability studies meeting regulatory requirements, in particular ICH guidelines Q1A(R2), B, D, and EDevelopment of cost-effective stability protocols for global markets, including climatic zone IVA and BAdvice on…

Quality Aspects

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

Knowledge and experience, alongside modern technology, allows manufacturers to predict manufacturing performance and quality, as opposed to 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.Our quality aspect servicesWe provide strategic and scientific/technical advice on the development…

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 (orphan drug, centralised, mutual recognition, decentralised procedure) is a critical element in this.To avoid delays in approval and marketing, the choice of reference member state and concerned member states for the mutual recognition and decentralised procedures is key.What 3R PHARMA CONSULTING can offer youConsultation on national…
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