Cooperations
For specific topics that have an important interface with regulatory questions, we have developed cooperations with other very qualified, competent and experienced colleagues.
Manufacture of Medicinal Products
We operate within a broad network of established contract manufacturers, who are able to produce almost all dosage forms and are ready to manufacture pilot batches for products in development.
Manufacturers and Suppliers of API
For chemically synthesized active pharmaceutical ingredients as well as for active moieties from plant origin and for ingredients used in nutraceuticals, we are in connection with many German and internationally operating suppliers.
Chemical-Pharmaceutical Tests
We develop analytical and chemical-pharmaceutical tests in accordance with regulatory requirements for your products and ask experienced and qualified companies to perform the tests in your name.
Galenic Development
You plan to improve the galenic formulation of your medicinal product and / or plan to develop a line extension?
Together with specialised companies we develop alternative options and accompany the development up to submission of the necessary documents to the relevant authorities of your product.
Stability Tests / Bio-Analytics
Furthermore and in cooperation with external laboratories, we take care of your stability tests under controlled conditions according to the requirements of ICH and provide you with the final results for submission.
We cooperate with several test laboratories that are specialised in the state of the art analysis of bio-samples that are obtained during clinical studies.
Medical writing
During preparation and evaluation of pre-clinical and clinical data, we are supported by experienced colleagues (native English speakers as well) with many years of expertise in this field.
Translations
Translations of medical-pharmaceutical documents, such as Patients Information Leaflets, Physicians Leaflets or SPCs into English will be carried out by native English speakers with a sound chemical-medical-pharmaceutical background.
We take responsibility for the final check and release of the translations and take care of the necessary final preparations to enable submission.
Pharmaceutical Law
Regarding sensitive issues related to the development of legally sound strategies, we cooperate with renowned law firms with experience and competence related to the legal environment of pharmaceuticals.
Clinical Studies
You plan do develop new chemical entities or line extensions for your existing products? Together with well-known and well-experienced CROs that cover all areas of indication, we can support you professionally and provide you with regulatory expertise.