PPD® Consulting
Our Experts are Your Experts
PPD is the ideal partner to help you ensure your biopharmaceutical product’s success from discovery through post-approval.
With more than 25 years’ experience, PPD brings diverse expertise across therapeutic areas and functional disciplines to provide biopharmaceutical consulting services throughout the product life cycle. Our experts work closely with you to develop customized plans that increase efficiency and reduce risk to help you realize your product’s value.
Direct Access to Industry Thought Leaders
PPD® Consulting gives clients direct access to industry-leading experts in the design and execution of full product development programs. Our consulting team is comprised of physicians, scientists, regulatory professionals and biostatisticians with extensive small and large molecule development experience and diagnostic/medical device expertise. These experts have first-hand knowledge of state-of-the-art clinical, regulatory and commercial program strategies from first-in-human testing through registration, including post-approval studies and product optimization strategies.
Product Development Consulting
With a long history of consulting in a wide range of therapeutic areas, our consultants have broad therapeutic knowledge and an in-depth understanding of global and local regulatory guidelines. PPD provides medical therapeutic area, regulatory and biostatistical consulting on a wide variety of product development and pharmaceutical development issues in all major therapeutic areas including oncology, cardiovascular disease and critical care, neurology and psychiatry, infectious diseases and metabolic diseases. PPD also has extensive expertise in the development of pharmaceutical products in rare diseases and pediatric indications, as well as in the development and approval of medical devices.
Specialization to Meet Industry Demands
PPD Consulting, in addition to the breadth of consulting expertise highlighted above, has experienced teams of physicians, scientists and other product development professionals with specialized expertise to help clients successfully navigate challenges and realize opportunities in the following areas:
- Biosimilars – PPD has significant experience in this relatively new but rapidly evolving arena and can provide clients the tools to meet the challenges in biosimilar development.
- China regulatory strategy – PPD leverages first-hand local knowledge and a strong presence in China to help clients succeed in this complex regulatory system and fully realize the potential of biopharmaceutical and diagnostic/medical device development in China.
- Adaptive trial design – PPD’s depth of in-house biostatistical, medical and regulatory expertise coupled with robust external collaborations provide clients with confident approaches to decrease cycle times and facilitate more efficient, less costly development.
- Cardiovascular outcomes studies – PPD draws from deep strategic development expertise in cardiovascular diseases, a large global footprint and strong operational skills to support clients in planning and executing cardiovascular outcomes programs which incorporate the most recent U.S. and European regulatory guidance.
PPD Consulting Gives You the Advantage
- Virtual entities as well as small or emerging biotechnology, pharmaceutical and diagnostic/medical device companies can take advantage of our development strategy and experience with regulatory agencies.
- For larger pharmaceutical and biotechnology companies, PPD can address gaps in strategic resourcing, enhance existing resources, or engage in longer-term joint development and planning activities as part of joint development teams.
- Customized services are available for small and large molecules, medical devices and companion diagnostics.
With staff in key markets worldwide, PPD provides the global infrastructure, experience and insight to expedite complex multinational product development programs leading to successful marketing approvals. Foundational to our expertise are:
- A commitment to transparency and collaboration
- Deep medical and therapeutic expertise
- Global regulatory consulting experience in major and emerging markets
- Cutting-edge biostatistical expertise
- Cross-functional product development leadership and program management services
- Flexible partnership approaches to working with a variety of large and small pharmaceutical companies, virtual development entities and nonprofits
For more information, please contact PPD Consulting.
