The definition of a medicinal product varies from one region to another; common definitions reflect a product’s intrinsic properties and its ability to exert a pharmacological effect in the treatment or prevention of disease. However, the way the product is presented and the claims that are made in relation to its use can also be important and should be addressed with care to avoid inadvertent encroachment into medicines legislation.
We provide a full range of consultancy services for companies working with prescription and over the counter (OTC) medicinal products. From regulatory planning and gaining authorisation for clinical trials, through to marketing authorisation and licence maintenance, we have experts who can guide you through your regulatory requirements.
We have specific expertise in:
- New active substances
- Biological products and chemical entities
- Advanced therapies
- Orphan medicinal products
- Borderline products
For a more detailed discussion on how we can help you, contact us on +44 (0)1628 530554 or email us via our contact form.REQUEST MORE INFORMATION