About Us

Experience. Excellence.

Through our long-standing mastery of technical and regulatory consultation services, Solutions International serves all areas of global regulatory compliance-related activities for the Pharmaceutical, Biotechnology, Biologics, CGT, Device and Allied Health Industries.

We serve a diverse base of loyal clients around the globe, from emerging-to-enterprise organizations across virtually any specialty of the life sciences.

The associates of Solutions International are proficient in the development, implementation and management of diversified projects involving scientific principles, technical aspects and regulatory requirements.

More than Forty Years of Achievement.

Advance. Confidently.

Since 1978, we have furnished expert compliance, regulatory affairs and technical services to clients around the world, helping avoid and resolve compliance problems, and assisting in the development of efficient and effective strategies for the submission and approval of drugs and devices.

Solutions International has set the industry standard through:

Senior Consultants.

Solutions team includes highly accomplished consultants who have a solid knowledge base, strong connections, and wisdom that can only come from decades of industry experience.

Efficient Engagements.

International Solution solve problems the first time – helping to ensure that you achieve desired outcomes quickly and more efficiently.

Integrated Expertise.

Solutions three practice groups collaborate extensively, ensuring that problems entrusted to us are addressed from all possible angles.

Senior Consultants.

Solutions International consistently delivers thoughtful, effective solutions, which is why clients repeatedly turn to us and refer others for help with their most challenging compliance and regulatory issues.

AREAS SERVED BY Solutions International

ADVANCE. CONFIDENTLY.

As long-standing leaders in technical and regulatory consulting services, Solutions International provides both experience and excellence through an unmatched team of respected industry professionals and SMEs.

PHARMACEUTICAL

TSI Consultants has an unsurpassed reputation for excellence in technical, regulatory consulting

PHARMACEUTICAL

TSI Consultants is proficient in the development, implementation, and management of diversified projects involving compliance, scientific principles, technical aspects, and regulatory requirements related to pharmaceutical products.
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Medical Device

TSI Consultants comprehensive list of services extends to all classes of medical device.

Medical Device

TSI Consultants comprehensive list of services extend to all classes of medical devices and combination products including In Vitro Diagnostics, Integral, Cross-labeled and Kitted Combination Products.
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BIOLOGICS

TSI Consultants has a reputation for demonstrated excellence in technical, regulatory consultation,

BIOLOGICS

TSI Consultants has a reputation for demonstrated excellence in technical, regulatory consultation, and guidance services for biologics, including cell and gene therapy, human cell and tissue products, monoclonal antibodies, biosimilars and many more.
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Trusted. Experts.

Solutions International multi-disciplinary team of DRAP and industry experts offers a full-range of compliance, regulatory affairs and technical services to clients around the globe.

Fran Zipp

President & CEO

Roy Sturgeon, Ph.D.

Chairman of the LCS Board of Directors

David Petshaft, Esq.

Chief Legal and Financial Officer

Global Solutions & Services

TSI Consultants serves a diverse base of global and loyal clients ranging in size from one-person startups to multinational corporations. TSI Consultants consistently produces high-quality results for clients regardless of size, geography, or specialty, including:

  • The world’s largest pharmaceutical companies
  • Medical device companies
  • Biotechnology companies
  • Emerging pharmaceutical companies
  • Dietary supplement companies
  • Law firms that serve pharmaceutical, biotechnology, medical device and/or dietary supplement companies
  • Investment firms handling mergers and acquisitions on behalf of pharmaceutical, biotechnology, medical device and/or dietary supplement companies

MISSION STATEMENT

TSI Consultant Services delivers the highest quality DRAP compliance and regulatory consulting services to the pharmaceutical, medical device, biopharmaceutical, and related industries.

Our mission embodies the following strategic factors:

  • Apply our expertise and experience to enhance the global availability of products that benefit mankind by continually improving our versatility, knowledge, and capacity to support client success.
  • Continually work to position the firm as the leading full-service provider to the global pharmaceutical and related industries in support of the development, regulatory approval, production, control, marketing and surveillance of pharmaceutical drugs, biotechnology-derived products, medical devices, veterinary products, dietary supplements and cosmetics.
  • Foster a culture that values professionalism and expertise, and our competencies of integrity, innovation, team collaboration, and passion for our business and the world around us.
  • Be the premier consulting resource, based on our record of consistently providing high-quality services that foster best business practices and consistently deliver timely, innovative, practical and cost-effective regulatory compliance solutions.
  • Provide high business value, based on a clear vision, sound management, effective operating processes, and technologies that are aligned with work needs, and the collaboration of a team that is highly qualified, talented and motivated.

DON’T MISS OUR LATEST WEBINAR

DRAP Manufacturing Compliance And Inspections For Cell And Gene Therapies and Other Innovative Biologics