services

Our experience as in-house as well as external counsel puts us in an optimal position to provide hands-on advice on the interface between science, business and applicable laws.

Currently, we support a wide range of clients from global top ten companies to small start-ups.

Life Sciences

We perform strategy- and documentation reviews and provide legal and compliance advice across the whole spectrum of product development and marketing activities.

Below are some of the life-sciences regulatory fields where we frequently advise our clients:

Compliance (see section “Compliance” for more details)
EU marketing authorisation (centralised and de-centralised) and certification
EU pediatric regulation

EU orphan product regulation
Regulatory data protection and interplay with related intellectual property rights
Biosimilars
Competition law / antitrust
Pharmaceutical marketing in the EU and in Switzerland, including for example:
- Interaction with HCPs, patient groups and other stakeholders
- Websites, communication challenges and opportunities
- Unfair competition

Competition Law

We are highly specialised in EU and Swiss competition / antitrust law and can support you on all related matters.

Examples of areas where we frequently advise clients are:

Dominant position – competition law challenges for companies and products with strong market presence
Interactions between actual and potential competitors – where are the legal limits for information exchange and collaboration between competitors, suppliers and customers?

Collaboration, distribution and supply agreements – avoiding the pitfalls associated with horizontal and vertical alliances
Competition law, innovation and highly regulated sectors
Sector investigations – what are the authorities looking for and what internal set up is needed to respond?
Competition law compliance – development, implementation and monitoring of internal codes of conduct, guidance and training
Analysis of internal documentation (e.g. business strategy plans) from a competition law perspective.

Compliance

We help you stay compliant in a complex and dynamic legal environment. Our philosophy is to develop sustainable solutions, fit for integration into your existing business structures and in line with your corporate ethical objectives.

Compliance solutions need to be defined on a case by case basis. We help you identify gaps and find appropriate remedies through analysis of sector and business specific risks as well as your existing structures and compliance tools. If needed, we can also perform audits into defined business areas to assess the effectiveness of your current compliance programs.

We have extensive experience developing:

Codes of conduct;

Internal guidelines and directives;
SOPs;
Suggestions for improved structures and optimisation of processes;
Compliance tracking tools.

In addition, we also provide on-site training, tailored to sector, client needs and functions. Areas where we have trained global and local functions are:

EU Competition law – how to behave in competition;
Interactions with healthcare professionals;
EFPIA’s new transparency rules – impact and to do’s;
Anti-corruption training – tailored to industry.

Legal Support

LEGAL OPINIONS
We perform tailored impact analysis of new laws, regulations and jurisprudence.

COMMERCIAL CONTRACTS
We can help you develop new contract templates or review and update your existing ones based on national and international legal environments.

A special area of expertise is competition law review of horizontal collaboration- and vertical distribution / supply contracts.

LPO (LEGAL PROCESS OUTSOURCING);
In case you are subject to litigation or regulatory inquiry, we help you screen and evaluate various types of documentation (e.g. contracts, emails, strategic plans).

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