An Overview of LifeSci Partners, LLC |
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Partners LLC: Biomedical Consulting |
Our mission is to help you to identify, develop and successfully com-
mercialize promising new therapeutic and diagnostic
technologies.
LSP accomplishes this goal by providing services in many areas of corporate and product development.
Business Development
LSP helps emerging companies and established firms identify and capitalize on core competencies, and select optimal corporate partners for expediting product development and commercialization. Descriptions of our business development services show how LSP's scientific and business expertise can assist your firm in crystallizing strategic development plans, assessing product opportunities, formulating an optimal licensing strategy, and developing and maintaining corporate partnerships. LSP also provides due diligence and analyzes strengths and challenges of emerging firms for venture capital groups.
Preclinical and Clinical Development Services
LSP's decades of experience provide a breadth of services to help you guide product development from preclinical testing to clinical efficacy trials. Clinical and preclinical services available include the framing of clinical development and regulatory strategies, design and management of preclinical studies and clinical trials, identification and recruitment of clinical investigators, and selection and management of contract research organizations.
LSP is highly skilled in many types of technical writing, including journal manuscripts, presentations, clinical reports, and regulatory documents needed from opening INDs to filing marketing approval submissions (New Drug Application, Biologics License Application and the European equivalents).
Other Services
LSP can assist with project management, the selection and qualification of contract laboratories and production facilities, and a wide variety of quality services, including validation protocols and reports, product specifications, compliance assessments, stability programs, and quality system design.
A Wealth of Experience
Your project will be completed
entirely by LSP’s principals, seasoned executives with
decades of experience in regulatory affairs, clinical affairs, and business and
corporate development. You will benefit from knowledge gained in achieving
more than 20 drug approvals from the US FDA.
LSP’s principals have worked in several therapeutic areas, including oncology,
immune and hormonal disorders, respiratory diseases, metabolic disorders,
coagulation and hemostatic disorders. Their development experience spans
biologicals, small molecule therapeutics, radiopharmaceuticals, in vitro
diagnostics and medical devices. They have worked with large pharmaceutical
companies and emerging biotechnology firms.
Your project will benefit not only from the expertise of LSP’s principals, but
also from the knowledge they have gained from working with an extensive
multinational network of clinical, business and academic colleagues.