Consumer Health

The consumer health sector might be slightly less regulated than classic therapeutical products as less active pharmaceutical ingredients (API) are processed, however the industry is still facing serious issues.

Over The Counter products (OTCs) do not require a physician’s prescription. This means they are delivered through pharmacies and sold in drugstores, supermarkets and other retail outlets. They are manufactured in large volumes. Typical consumer health products fall into the categories of pain relief, oral health, nutrition/gastro-intestinal, skin health and respiratory. And they are required to meet strict industrial and logistics criteria’s.

But despite their soft therapeutical action, OTCs are still under scrutiny by the health authorities.

We work with our clients to help them address a broad range of issues. From those arising through the product development phase to the manufacturing, distribution and marketing challenges. Whatever aspect you’re seeking advice on, we’re confident we can help.

Our teams across international regulatory, market access, corporate, commercial and IP support our clients worldwide. From a products (inter)national launch and compliance procedures to product liability and pharmacovigilance.

We have experts to help you on:

• R&D contracts
• Clinical trials
• Manufacturing agreements
• Product classification
• Market access and CE marking
• Pricing and reimbursement
• Supply chain and distribution
• Advertising and promotional activities
• IP/patents (life cycle strategies)
• Data and regulatory exclusivity
• Regulatory enforcement and (criminal) sanctions/compliance
• Industry codes of conduct/self-regulation
• Transparency – data and relationships with healthcare professionals
• Administrative/public law
• Public/private partnerships with healthcare institutions
• Product recall and liability
• Business development & partnerships.