- About us
- Regulatory Affairs
- Pharmacovigilance & Med. Affairs
- Quality & Manufacturing (GMP)
- Business Development
Lifecycle management for your products
We provide regulatory support throughout the lifecycle of your products. Our services are tailored to your needs and cover all aspects of lifecycle management including
- preparing variations
- managing MA renewals
- sunset clause related marketing
- interim management of your Regulatory Affairs department, on-site or remotely
Variations
During the lifecycle of a medicinal product, many variations will be required in order to keep the dossier up to date. The effort required for implementing a variation will largely depend on what’s changed in the dossier. For minor variations like administrative changes it will be sufficient to notify the competent authority while major variations, e.g. significant changes to the Patient Leaflet or the manufacturing process, require regulatory approval. Marketing authorisation holders are also required to monitor the current state of scientific knowledge and adapt their products and texts accordingly.
We help you develop the best regulatory strategy for implementing any required changes, including correct classification and grouping of variation in order to reduce time and effort. Depending on your requirements, we prepare and submit individual variations or provide comprehensive ongoing support.
Renewal of marketing authorisation
Every new marketing authorisation needs to be renewed once after 5 years. Old marketing authorisations will also require one more renewal unless they are already valid for an unlimited period.
We monitor deadlines on your behalf, submit your renewal applications on time in compliance with national requirements and provide clinical and technical advise on questions raised by authorities, e.g. concerning production, quality control or long term and in-use stability.
Sunset clause
When a product is not marketed for 3 years, the marketing authorisation will be terminated automatically due to the sunset clause.
We help you prevent termination of your marketing authorisations.
We even own a wholesale distribution authorisation and have the necessary means to market products under our own name if threatened by the sunset clause.
Interim management
When there’s a staff shortage, we take over as interim management of your Regulatory Affairs Department on-site or remotely in order to ensure business contingency.