Regulatory strategies
The best possible acceptance for your products
Use your time and financial resources to the best effect. The efficient input of resources plays a key role in obtaining marketing authorisations for generics, biosimilars and advanced therapies, as well as authorisations based on bibliographical data. At an early stage we evaluate your product developments with a view to acceptance.
We analyse:
- regulatory acceptance
- pharmaceutical composition
- intended use (indication)
- dosage
- safety-related information
Your regulatory strategy
We support you from the very outset of your development project and design a specific regulatory strategy. In this context you delineate your marketing objectives, target markets and product characteristics.
Expert advice on advanced therapies
Our experience with advanced therapies dates back to the period before the relevant EU regulations came into force. We are fully aware that – in the absence of a clear regulatory concept from the very outset – all new developments contain a large element of risk. In this context we provide in-depth advice and establish contact with the regulatory authorities.
We are familiar with the differing priorities of the European authorities
You will also be aware of the fact that, despite the various harmonisation efforts over the years, the European regulatory authorities still diverge significantly in terms of their working practices and evaluation priorities. The EU directives leave scope for interpretation. To a certain extent this scope is narrowed down (for example) by the communications issued by EU Commission and the deliberations of the CHMP/CVMP/CMD. An additional factor is the growing number of publications by EU institutions and the rulings of the European Court of Justice.
On your behalf we:
- analyse the acceptance of specific indications/substance classes by the national regulatory authorities in the European countries;
- make allowance for the differing reputations and decision-making durations of the European regulatory authorities;
- select the appropriate marketing authorisation procedure (centralised, decentralised, national);
- define the relevant regulatory reference basis;
- demarcate potential options (new marketing authorisation, variation, line extension);
- prepare and conduct prefiling discussions with the regulatory authorities.
