Our Life Sciences team acts for all the industries in the sector including pharmaceutical, biotechnology, medical devices, cosmetics and food companies in regulatory, compliance, intellectual property and product liability, in both contentious and non-contentious matters.
Our team has a leading practice on regulatory issues in dealing with:
• Conducting regulatory audits;
• Advising on labeling and packaging issues;
• Advising on advertising and promotion of medicinal products;
• Advising on market access issues;
• Advising on pharmacovigilance issues and drafting SDEAs;
• Drafting clinical trials agreements;
• Litigation regarding marketing authorization withdrawal and suspension;
• Drafting transfer of marketing authorization files;
• Drafting of commercial agreements: Co-marketing, distribution, collaboration agreements.
Regarding compliance issues, our team has advised on:
• Advising on compliance issues and in particular on the French and European regulations applying to the grant of gifts and advantages to medical doctors by a medical devices company;
• Advising on hospitality issues and drafting of a internal guidance of how to handle hospitality and sponsorship;
• Review of Codes of Ethics;
• Conducting of compliance due diligence.
Our team has a broad range of IP/ IT experience. Our areas of expertise include:
• Conducting IP portfolio due diligences;
• Drafting and negotiating license agreements, R&D and collaboration agreements;
• Drafting and negotiation of intellectual property acquisitions, and other transactions aimed at exploiting IP assets;
• IP advises;
• Obtaining the status of health data host operator;
• Advising on data privacy issues;
• Reviewing the content and the terms and conditions of companies’ websites and of health websites;
• Advising on connected devices;
• Advising on health software.
Our expertise also includes advising companies on product liability issues (contentious and non-contentious matters).
For cross border files, we are used to coordinate the work performed by several law firms for our clients.
PDG Avocats is member of the Conference Bleue, a network of 22 experienced, independent European law firms specializing in pharmaceutical law. (Website: www.conference-bleue.com).
PDG Avocats has created privileged links with law firms specialised in administrative law, competition law and IT law.
Our lawyers are able to assist clients and to work in French, English, Spanish and German.