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?
QM Systems
Support for the implementation of complete Quality Management systems or single Standard Operating Procedures.
Qualifying/Validation
Qualifying and Validation of Processes, installations, methods and computerized systems.
Wholesale Distribution Authorization
Support in obtaining a Wholesale and/or Manufacturing Authorization according to German Medicinal Law (AMG).
External staffing of AMG functions
Responsible Person §52a AMG, Manager Manufacturing, Quality control or Quality Assurance.
IT Validation
Your contact for all IT questions in Pharma (including validation according to GAMP 5).
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.
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).
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.
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.
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.
