For over 30 years, the Partners, Principals and Premier Experts of NDA Partners have helped pharmaceutical product and medical device companies address their greatest challenges, from selecting the right compound to enter the clinic, to designing highly efficient clinical development programs and successfully navigating the regulatory process.
Successful medical device development requires a streamlined regulatory path that takes advantage of the risk-based regulatory approach adopted by FDA and Europe.
There are regulatory steps along the total product life cycle that need to be managed with the scientific and regulatory challenges of new product development.
We work with our clients in many ways, for example:
- Helping a discovery-oriented management team transform their business into an efficient product development and commercialization organization.
- Evaluating products that have failed in early-stage clinical trials to assess their potential for alternate indications and markets.
- Identifying the products from a client's discovery pipeline that will have the highest probability of development success.
- Designing a rapid path to Proof-of-Concept that is scientifically sound, fully integrates prior knowledge with newly developed data, and conforms to accepted regulatory outcomes.
- Guiding the design of clinical development programs that are based on sound scientific, regulatory and market principles, appropriate use of modern methods, and that follow a minimum cost path to regulatory approval.
- Helping a troubled company that has failed to achieve its potential re-direct its product development effort.
- Providing a comprehensive blueprint for establishing a cost-effective and flexible clinical development infrastructure, including systems, guidelines, standards and processes.
- Assessing the likelihood that a development candidate will become an approved product for venture capital companies and large financial institutions.
- Preparing for key interactions with regulatory agencies, whether routine, proactive or reactive.
The examples above help explain who we are and what we do. Our mission is to dramatically improve the success rate and development speed of biopharmaceutical discoveries. We will accomplish this through the outstanding advisory services of our teams of Premier Experts and our knowledge of and access to the best medical product development resources in the world.