Soldan Regulatory Consultancy - SRC

What We Offer: Strategic Expertise and Operational Excellence

Soldan Regulatory Consultancy (SRC) provides to the pharmaceutical industry a wide range of regulatory services during the complete life cycle of a medicinal product, with a focus on biopharmaceutical and biotechnology products (to be) registered in Europe and USA.

SRC is committed to helping your company to obtain license approval for your pharmaceutical products in a timely and cost-efficient manner and to keep them on the market safely.

SRC´s services range from guidance and strategic advice to hands-on collaboration, from early product development to post-licensing support, and from short- to long-term projects.

SRC´s clients are small, medium-size and large-scale biotech and biopharmaceutical companies.

SRC holds alliances with other consultancies (regulatory, quality, clinical research, clinical quality assurance), allowing for a full range of service offerings.

Who We Are

Dr. Sabine Soldan, SRC´s founder, has more than twelve years experience in international Regulatory Affairs in the pharmaceutical industry, with a focus on European and US. She worked in the international plasma products and vaccines business in several leading Regulatory Affairs positions.

Dr. Soldan has first-hand experience and expertise to perform a wide range of regulatory consultancy services to meet your company´s specific needs. She is also an experienced manager of teams of regulatory professionals.

Since the foundation of her Regulatory Affairs consultancy end of 2008, now named SRC, she has worked on numerous international projects.
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What We Promise

Your completed work is delivered in high quality, timely and within budget.
Data security and confidentiality is assured to the highest level.