Regulatory and investigations

Recent experience includes:

Medical device company compliance advice

Advised medical device companies on compliance matters for the manufacturing and selling of products in EU, US and Asian trade markets.

Regulatory authority investigation

Represented a European based veterinary drug manufacturing company during preliminary investigations by the European Medicines Agency regarding breaches of internal regulatory compliance procedures and the conditions of its marketing authorisation.

Internal investigation

Conducted an urgent and extensive investigation into concerns raised regarding the implementation of pharmaceutical research protocols the reporting of their results.

Medical device manufacturer

Health & Safety advice to a medical device manufacturer company, including review of risk assessments.

Medicines manufacturer

Defending a medicines manufacturer in respect of alleged breach of licensing regulations.

Pharmaceutical company

Advice as to the use for medical purposes of a device containing controlled drugs.

Medical device manufacturer

Advising and representing medical device manufacturer in a coroner’s inquest into the death of a patient potentially owing to the faulty design of the client’s device.

A biochemistry laboratory

Advised in relation to the potential impact of Brexit on the regulatory framework governing clinical trials in the UK.

International Distributor

Advised on the regulatory framework governing the sale of medical face masks and face coverings.

Diagnostics Company

Advised on the application of the In-Vitro Diagnostic Medical Device Directive to sample preparation kits for Covid-19 tests and whether a CE mark was required prior to sale.

Regulatory and advertising advice

Providing regulatory and advertising advice in relation to our client's OTC moisturising creams and medicated shampoos