Health Care

The healthcare practice group stands for expertise and decades of experience in providing advice and representing clients in the healthcare sector. We support and advise our clients on all issues involving pharmaceuticals, medical products, cosmetics and food, from “A” to “Z”. The main areas of activity are regulatory, R & D, production and distribution, advertising and competition, labelling, inspections and complaints, contract management, reimbursements, crisis management and delimitation of responsibility. In addition, we are regularly involved in legal due diligence processes with a focus on regulatory issues in the course of mergers and acquisitions in the pharmaceutical, food and medical products sectors.

You will meet us in professional associations and as lecturers at conferences, seminars and other professional events and can read about us in professional journals. We additionally share our knowledge in company-specific in-house training courses with a practical focus. Our activities in the relevant associations keep us up to date with the latest legal developments in each sector.

KLEINER Rechtsanwälte advises and represents companies in the pharmaceutical industry, from the development through the production to the marketing of the product. Our clients include domestic and international companies of all sizes. Our services include:

• Market entry (development and approval of pharmaceuticals plus questions of reimbursements)
• Contact design e.g. for clinical studies and application observations, cooperation agreements, third party manufacturing, marketing and sales, co-marketing, VAV, licensing, domestic and international distribution
• Support regarding permits for production, storage and wholesale
• Compliance
• Advice and representation in monitoring actions undertaken by the authorities
• Advice and representation in unfair competition disputes
• Pharmaceuticals co-vigilance

KLEINER Rechtsanwälte also advises and represents companies on the cosmetics market in all legal issues, from the product development process through to the product marketing and sale. Our clients thereby profit from our expertise and experience with all the advantages of consulting from a single source. Our services include among others:

• Legal support of product design and labelling
• Drafting of contracts, particularly contracts for third party manufacturing, delimitation of responsibility and distribution agreements
• Marketing and advertising
• Representation in official objection proceedings
• Advice and representation in competition disputes

The medical products industry in Germany must be highly innovative in order to fulfil the constantly growing requirements of users. Not only technology, but also the legal framework is subject to change and poses ever greater challenges to market participants. KLEINER Rechtsanwälte supports companies in the following areas:

• Market entry (conformity assessment processes, representation towards ”notified bodies” and authorities plus issues of reimbursement)
• Delimitation of responsibility and product classification
• MedTech compliance, particularly structuring and review of admissible distribution and marketing strategies plus drafting legally secure contracts
• Risk management (support in case of product recalls and product liability)
• Product design and labelling

KLEINER Rechtsanwälte advises companies operating in the food market on all legal issues concerning their products. We legally secure the development process, from the name through the design to product safety and marketability. Among others, we are specialised in the following areas:

• Nutrition supplements, novel food, food for special medical purposes (balanced diet), food for general consumption
• Labelling and advertising
• Marketing and disputes regarding unfair competition
• Monitoring actions undertaken by the authorities
• Crisis management (e.g. recalls, public information)

KLAR. KLEINER