Regulatory services
With our many years of expertise in medicinal products with chemical, herbal and biotechnological active ingredients, we support you in the regulatory issues of product development and drug safety.
Regulatory support during product development
The efficient development of new product formulations requires an overall knowledge of regulatory requirements already at an early stage.
We efficiently guide you through the various development phases and support you in the development of a regulatory strategy and in implementing regulatory requirements in a changing environment. We also offer further support from clinical and preclinical experts from the HWI network.
Benefit from our knowledge gained in development of numerous human and veterinary medicinal products with chemically defined active substances, phytopharmaceuticals and biological medicinal products, which we have accompanied or carried out independently on behalf of clients. Our services include:
- Regulatory and strategic advice
- Compilation of Briefing Books as well as submission and coordination of Scientific Advices
- Compilation of IMPDs/INDs for clinical studies, incl. amendments during the study, if required
- Evaluation of the results from the development process concerning their technical suitability and regulatory compliance
- Compilation of the dossier for the Marketing Authorisation Application
- Processing of requests from authorities (e.g. Request for Information, Deficiency letters)
- Gap-Analyses, e.g. of IMPDs or individual reports (e.g. method validation reports)
- Management of projects and procedures
Regulatory support in the context of drug safety
To ensure drug safety, it must be assured that the product information complies to current regulatory requirements. In addition, it must be assured that safety-relevant changes, e.g. due to PSUSA procedures, are implemented in a timely manner.
We will be pleased to take over the compilation and maintenance of the Labelling as well as the Summary of Product Characteristics and Package Leaflet of your medicinal product.
Contact us. We’re happy to help!
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