Marketing Authorisation

Temmler's regulatory department has gained extensive experience over many years in regulatory affairs on medicinal products (chemical /herbal, solid/semi-solid/liquid/sterile formulations) and medical devices, not only within the national environment in Germany but also within the EU and worldwide.

The spectrum of marketing authorisation activities ranges from

• the implementation of dossier audits,
• the compilation of the CMC documentation including the Quality Overall Summary,
• the coordination of the external procurement of non-clinical and clinical overviews including the respective documentation,
• the preparation and submission of IMPDs,
• the compilation of entire marketing authorisation applications,
• the implementation of national MR- and decentralised licensing procedures,
• the preparation and implementation of variation procedures,
• the handling of complaints
• the complete updating of the chemical-pharmaceutical documentation,
• to the adaptation of registration dossiers to state-of-the-art technology
• and the provision of continuous product maintenance

We are thus able to offer a full range of regulatory expertise ranging from consultation services in connection with product development or in-licensing projects, the provision of regulatory assistance regarding marketing authorisation procedures, the compilation of marketing authorisation applications for existing products to full product maintenance during the life-cycle of a product.

The organisation of the marketing authorisation process focuses on a project-accompanying compilation of dossiers in close cooperation with R&D, with short preparation and submission times for marketing authorisation applications. The Regulatory Department is thus involved in development projects at a very early stage and is able to ensure regulatory compliance in an environment in which requirements and guidelines undergo constant changes. At the same time, the Regulatory Department acts as a link between R&D, Production, Medicine, Marketing, Regulatory Authorities and external service providers and is therefore able to better co-ordinate and target their efforts on the course of the development project, thus ensuring a smooth marketing authorisation process.

We offer our customers a full marketing authorisation service that does not only include the maintenance of products developed in our own company but is also available for customer products that are contract-manufactured by Temmler. In this way, we are in a position to apply our regulatory expertise to products that are to be transferred to Temmler Pharma & CO. KG (update of dossiers, preparation of variations), and we are also able to assume responsibility for the product's full life cycle.

We do of course also offer our regulatory expertise for products not manufactured by Temmler, which can help relieve bottlenecks in our customer's own regulatory departments.

We look forward to offering you advice and information at any time and without obligation.