Dr. rer. nat. Jens-Uwe Junghanns, Pharmacist

Solutions for
Pharma and
Life-Sciences

With more than 15 years of experience in Pharma, Life-Sciences and IT we can support you in applying for a Wholsale Distribution Authorization (§52a AMG)
Dr. rer. nat. Jens-Uwe Junghanns, Pharmacist

Streamlining the application process

With more than 15 years of experience in Pharma, Life-Sciences and IT we can support you in applying for a Wholsale Distribution Authorization (§52a AMG)
Our Services

Whether wholesale authorization, QM systems or external staffing of AMG functions - Services at a glance.

Do you need support in obtaining a manufacturer's or wholesale authorization according to AMG? Do you need support in designing your QM system or individual SOPs? Are you looking for help with the qualification and validation of methods, software, equipment and devices?

Handschlag

Our network of experts

With more than 6500 contacts on board level on Linkedin and a personal offline Network grown over many years, the correct anwers to your questions and the solutions to your problems are just one step away.

Case Study

Introduction of a Hepatitis medication into the market.

Process
1

Contact

We were contacted by a biotech company in April of 2019. We were tasked to find the most efficient solution for the regulatory and legal realization of the market introduction. We provided a Responsible Person (§52a AMG).
Process
2

Wholesale Dristibution Authorization (WDA)

Starting in May of 2019 we began implementing a specific Quality Management and Assurance System and coordinated the application process with the competent legal authorities for obtaining the WDA. The WDA was granted in July of 2019 after successfully passing inspection.
Process
3

Market Authorization

After successfully introducing the product in several European early Access programs (e.g. France) the product was granted Market Authorization by the EMA in several European countries.
Process
4

Result

In December of 2020 our client’s company was purchased by a US-based index noted pharma and biotech company for more than 1 billion Euro.

We are happy to help.

Feel free to call or email us with your project.

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Postal address

German Capital Pharma GmbH
Badstraße 20
13357 Berlin
Germany

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