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LIFE SCIENCES LAW – Ralph Schäfer – Lawyer
Lawyer for Pharmaceutical and Biotech Law
Your partner for legal issues in the life sciences industry
From start-up to established company
The pharmaceutical and biotechnology industry is at the heart of medical innovation. New active ingredients, biotechnological processes, personalized therapies, and highly specialized products are rapidly transforming healthcare. At the same time, companies operate in an environment characterized by high investments, long development cycles, complex approval processes, and a special responsibility to patients, physicians, and the public.
Pharmaceutical and biotech companies must continuously reconcile scientific excellence, regulatory requirements, and economic objectives. Decisions made in early development phases directly impact subsequent approval processes, production structures, market access, and liability risks. At the same time, the pressure is increasing to bring innovations to market efficiently, transparently, and sustainably.
Life Sciences Law supports companies throughout the entire lifecycle of pharmaceutical and biotechnological products. From the early development phase through clinical programs and market launch to ongoing post-market surveillance, we provide consulting services that speak the language of the industry and understand its practical processes. Our focus is on solutions that create security, stabilize processes, and support strategic decision-making.
Complex value chains and international structures
Pharmaceutical and biotech companies often operate internationally. Research, development, manufacturing, and sales are spread across various locations, partners, and markets. Collaborations with research institutions, contract manufacturers, licensing partners, or clinical trial centers are an integral part of their business model.
These structures require clear responsibilities, robust processes, and proactive planning. Life Sciences Law helps to organize complex value chains in a legally compliant and economically sound manner. The goal is to avoid friction, clearly define interfaces, and identify risks early on.
Innovation, growth and responsibility
Especially in the pharmaceutical and biotech sectors, innovation is inextricably linked to responsibility. New therapies must not only be effective, but also meet the highest standards of safety, quality, and transparency. At the same time, companies face the challenge of securing investments, enabling growth, and positioning themselves competitively.
Life Sciences Law understands this balance. Its consulting services are designed to enable innovation without losing sight of risks. Entrepreneurial decisions are supported in a way that ensures long-term sustainability and combines regulatory stability with economic viability.
From start-up to established company
The industry is diverse, ranging from research-driven startups and medium-sized specialist providers to internationally operating pharmaceutical and biotechnology companies. Each company faces its own unique challenges, whether entering the market, scaling up, forging collaborations, or managing day-to-day operations.
Life Sciences Law provides tailored, cross-industry legal advice. The collaboration is personal, pragmatic, and based on mutual respect. The goal is to support companies in the pharmaceutical and biotech sectors so they can focus on their core competencies while regulatory and strategic issues are resolved clearly, systematically, and reliably.
Submit your inquiry now
We will gladly advise you comprehensively and personally on your request.
Submit your inquiry now
We will gladly advise you comprehensively and personally on your request.
Why Life Sciences Law?
Life Sciences Law Ralph Schäfer combines specialized legal advice with genuine leadership experience from the life sciences industry. Admitted to the bar for 27 years, he has held various roles as in-house and external legal counsel and business manager in international companies, including General Counsel and board member of a publicly listed biotech company, as well as in associations.
These include, among others:
- 10+ years as General Counsel and Corporate Counsel international, publicly listed medical technology, biotech and pharmaceutical company
- Long-standing responsibility in senior positions, long-time member of the management team, and as a board member of a listed biotech company, with a focus on law, compliance, strategy and regulation
- Extensive experience as a compliance officer of a publicly listed biotech company
- Extensive experience at the interface of pharmaceuticals, biotech, medtech and health care
- Solution finder, strategy partner and legal guide for executive and supervisory boards
This combination of legal expertise and operational management practice enables the firm to provide advice that is legally precise, economically viable, and practically implementable. The firm stands for personal, pragmatic, and ethically oriented support in the highly regulated life sciences environment.
FAQs – Frequently Asked Questions in the Pharmaceutical & Biotech Industry
The pharmaceutical and biotech industry includes traditional drug manufacturers, biotechnology companies, research-oriented start-ups, contract developers, contract manufacturers, active ingredient producers, and companies from adjacent fields such as cell and gene therapy or personalized medicine.
Typical characteristics include long development cycles, high investment costs, complex regulatory requirements, international structures, and strong pressure to innovate and compete. Decisions must be made early and strategically.
Regulatory requirements affect virtually all areas of a company, from research and development and clinical programs to manufacturing, sales, and market surveillance. They are a key success factor for market access and economic stability.
Support is beneficial even in the early stages of development, such as product conception, choosing the regulatory route, or structuring collaborations. Early clarity reduces later risks and delays.
Collaborations with research institutions, contract manufacturers, licensing partners, or investors are typical. They require clear contractual structures and a clear delineation of responsibilities along the value chain.
Pharmaceutical companies often work with traditional chemical agents, while biotech companies utilize biological processes and living systems. In practice, however, the two fields are increasingly overlapping, particularly in innovative therapies.
Increasingly relevant are personalized medicine, biologics, cell and gene therapies, digital companion products, sustainable production processes, and international supply and development structures.
Start-ups and scale-ups drive innovation, but face particular challenges in financing, market entry, and scaling. Clear structures and strategic planning are especially crucial here.
Pharmaceutical and biotech companies operate at the intersection of science, business, and regulation. Consulting is particularly valuable when it understands the industry's internal processes, decision-making mechanisms, and market mechanisms.
Life Sciences Law supports companies, particularly with complex development projects, strategic decisions, collaborations, market entry issues, or during phases of growth and reorientation. The goal is to create certainty and provide a sound basis for entrepreneurial decisions.
contact
Your law firm LIFE SCIENCES LAW - Ralph Schäfer – Lawyer.
- +49 8151 4466683
- ralph.schaefer@lifescienceslaw.de
-
Munich Street 33
82319 Starnberg