Having industry specific expertise available to support you through the local regulatory environment provides you with peace of mind and confidence that your project is being handled appropriately.
Our consultants have many years’ experience working across the industry sectors and you can be confident that we have a multidisciplinary team of experts to provide you with that specialist knowledge and guidance.
Our diverse range of clients means we have a wealth of technical and practical experience. Therefore no matter what your requirement, we can assign the most experienced regulatory or pharmacovigilance consultants to support your project.
More information on the sectors we specialise in can be found by selecting the relevant section below.
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
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.
Some products, often depending on the way they are presented, can have more than one potential regulatory classification and therefore correctly categorising them and applying the appropriate legislation is a key challenge.
We specialise in the borderline between medicines, devices, nutritional products and cosmetics, and are experts in preparing robust written cases for demarcation where doubt could otherwise prevail.
The range of products which fall under the medical device umbrella is vast. Divided into distinct classifications – devices covered by the Medical Devices Directive (in the EU) to active implantable medical devices, and in-vitro diagnostic medical devices – the regulations are complex and differ from country to country. The purpose of the legislation is to ensure that devices achieve a mandatory safety standard.
Contract Research Organisations (CROs) are independent organisations that provide the pharma and biotech industries with specific research services. This may include providing key data to support biopharmaceutical development, commercialization, preclinical/clinical research and clinical trials management.