Project Manager Regulatory CMC (m/f/d)
(20 hours part time)
Deutsche Apotheke Zeitung | 159. Jahrgang | 10.01.2019 | Nr. 1/2
EMA and edqm ask MAH to evaluate the risk of nitrosamines in marketed synthetic drugs. Risk assessment has to be conducted for drug substance, excipients and drug product. RD&C will assist clients.
Prof. Ulrike Holzgrabe (University Wuerzburg) and Helmut Buschmann (RD&C) published a recent article in DAZ on Remifentanil
Concept Heidelberg/ECA invited Helmut Buschmann and Norbert Handler to give talks for the workshop "Stability by Design". The 2-day course will be held in Hamburg on April 19th to 20th 2018.
The method could be used for prediction of stability, polymorph changes, shelf-life, degradations in solid environment as well as development tool for solid formulations. The service is offered to customers, but is also open for out-licensing.
The strictly regulated trade "Consulting Engineer" warrants a broad technical expert background with an objective view, directed towards protecting the clients’ interests and ensuring superior performance at the lowest commensurate cost. It includes an expert status in the field ensuring quality, employability and professional recognition.
The expert status is announced for 5 years comprises the fields pharmaceutical chemistry, pharmaceutical products and cosmetics.
RD&C can act as one-stop-shop for your DMF-application at NMPA in China (including translation, contact to authorities, registration account, regulatory support). Please contact us for more information.