EU REGULATORY AFFAIRS PRACTICE

Regulatory Affairs span virtually every industry sector:

1. Pharmaceuticals
2. Veterinary Medicines
3. Medical devices
4. Pesticides
5. Agrochemicals
6. Cosmetics
7. Complementary Medicines
8. Automotive
9. Chemicals
10. Energy
11. Fast-moving consumer goods
12. Food and feed
13. Information technology
14. Internet
15. e-Commerce
16. Life sciences/biotechnology
17. Media & Entertainment
18. Telecommunications
19. Tobacco
20. Betting and Gambling

Complementary fields of law

1. Intellectual property
2. Competition law
3. International trade

EU Regulatory Practice (Full Range of Services)

1. Advising clients on all aspects of marketing and brand protection
2. Advising on EU regulatory laws and standards to ensure compliance across all the EU member states.
3. Helping clients identify and manage risks as they develop strategies to maximize business growth.
4. Monitoring the latest legal developments that affect  clients.
5. Assisting clients in lobbying at both national and EU level in relation to new legislative and policy proposals.
6. Counseling clients where necessary on litigation before national and EU courts.
7. Assisting clients throughout their product’s lifecycle – from manufacture to disposal (consumer and industrial product manufacturers, component suppliers, and sellers and distributors; and clients seeking to extend their valuable brand names into new product areas.
8. Assisting clients in the identification of applicable EU and member state legislation and standards; the registration of product components (e.g. under REACH and Biocides Regulations or the General Product Safety Directive); the choice of favorable customs treatment and end-of-life options.
9. Registration of the product with the relevant authorities
10. Development of liability risk profiles prior to sale
11. Design of distribution chains and the drafting and negotiation of distribution contracts
12. Negotiation concerning pricing and reimbursements
13. Protection of intellectual property rights
14. Marketing, promotional campaigns and product labeling compliance
15. Obtaining of necessary authorizations; and compliance with consumer rights legislation.
16. Resolution of regulatory and enforcement issues and the assessment of risk product liability litigation and the coordination of corrective actions (recalls etc.)
17. Minimizing of consumer risk while preserving brand integrity
18. Advice on consumer research.
19. Court actions e.g. existence of competitors’ illegal products on the EU market; defense against third-party claims (e.g., of failure to comply with regulatory obligations); counterfeit and the infringement of copyright-protected content; wrongful use of advertising and unfair commercial practices; complaint to the European Commission against member states for noncompliance with EU legislation.
20. Advice on export controls and sanctions (Monitoring, analyzing and reporting on developments in rapidly changing web of laws and policy, and conducting internal reviews, investigations, responding to government inquiries and agency interventions.
21. Addressing customs issues for global clients
22. Monitoring WTO-related issues
23. Providing strategic counseling and risk analysis
24. Privacy compliance programs and privacy policies for clients.
25. Advice on data protection obligations (such as the retention and transferal of customer data) and on direct marketing issues.
26. Advising clients on internet/email monitoring, the use of cameras, and on social media in the workplace.
27. Advising clients on the advertising of their products and all regulatory aspects relating to the marketing of their products
28. Helping clients to assess the legality of their competitors’ marketing practices
29. Advising clients on restrictions with regards to promotional offers
30. Internal audits and reviews of company guidelines
31. Representation in the event of misleading, aggressive and/or comparative advertising
32. Advising public institutions and local and multinational companies on a broad range of criminal matters.
33. Raising awareness of potential criminal liability and increasing clients’ understanding of their professional responsibilities
34. Organization of internal training programs and developing compliance programs and client codes of conduct.
35. Assisting in interactions with regulatory authorities and defending  clients in court when necessary. Typical areas may include public and private bribery, breach of trust and misappropriation of funds, theft, concealment, forgery, fraud, infringement of labor law, and offenses related to IP rights (e.g. counterfeiting).
36. Monitoring evolving EU legislation that affects clients.
37. Helping clients navigate the intricacies of the EU rule-making process. This allows clients to influence developing legislation and potentially limit its impact on their businesses.
38. Proactive monitoring that provides clients with advance warning of changes to legal regimes, affording them lead time to adapt product design, sourcing, or manufacturing, and thereby reduce cost.
39. Advising clients with public procurement and competitive tendering procedures.
40. Advising clients both in relation to the generally applicable rules and with respect to their own particular tenders.
41. Full range of services to bidders and contracting authorities covering the procedures and requirements relating to the award of public contracts as well as EU and NATO procurement rules and assisting clients at every stage of the tendering process.
42. Where necessary, challenging public authority decisions on behalf of clients, and advissing on Public Private Partnership projects.