Regulating Life Sciences

Life Sciences companies are operating in a rapidly changing and increasingly demanding regulatory environment. Innovation, safety and value for money are major challenges. Well devised strategies add significant value. Breach of regulatory laws and codes attracts criminal and civil sanctions.

Simmons & Simmons has a leading European regulatory practice that advises on a full range of regulatory issues affecting medicines, medical devices, tissues/cells, foods and cosmetics. Our sector expertise, active membership of influential trade associations and long standing relations with European and national regulators means that our clients receive innovative and commercial solutions to complex regulatory problems. 

Biotechnology companies

• advising on clinical trials, orphan drug designation, marketing authorisation procedures, data exclusivity, supplementary protection certificates, pharmacovigilance and EU personnel requirements.

Pharmaceutical and medical device companies

• advising on promotion materials and activities in relation to medicines and medical devices, including conference booths and materials, dealings with healthcare professionals, pricing disputes and compliance procedures.

Major chemicals company

• advising on GMP requirements for chemicals used in the manufacture of medicinal products, cosmetics and foods. 

Companies dealing with human cells

• advising on procurement, importation, distribution, storage and research of human cells.