Project Management

RPI offers strategic and tactical regulatory expertise in all phases of drug development to organizations ranging from early-stage startups to some of the world’s largest life science companies. Our experts leverage their comprehensive submission experience to strategically position and guide clients through a streamlined and customized approach that helps them achieve their drug development goals.

RPI’s project management services include:

Strategic drug development assessment and planning
Product development
Strategic project management and tactical planning

Strategic Drug Development and Planning

RPI’s experts:

Provide an independent assessment of the development program
Assess the regulatory precedents and landscape to make recommendations on the most efficient path to meet development milestones
Identify critical path items early and devise risk management solutions
Provide experienced resources to lead or assist in managing programs via established processes and reporting
Provide targeted support to remediate distressed programs and get them back on track

Product Development

RPI offers strategic and tactical product development expertise at all stages of drug development. We provide product development advice and tactical guidance grounded in decades of experience. You can:

Leverage our team’s decades of experience
Rely on our dedicated team in your project
Trust RPI to deliver superior results

Strategic Product Management and Tactical Planning

RPI provides:

Management of strategic planning and coordination of cross-functional teams to accomplish corporate objectives
Project management leadership with strategic input on development plans and identification of the most efficient path to meet development milestones
Risk management solutions to critical path issues
Experienced resources to lead or assist in managing projects via established processes and reporting

After having worked with RPI for many years now, my expectations were naturally high. Once again, RPI’s outstanding staff delivered, on time, a clean submission. I deeply appreciate RPI’s depth of experience in terms of both regulatory strategy and publishing operations.

Jamie Cope

VP – Translational Medicine, Reset Therapeutics

RPI was founded in 1995 to serve the growing needs of small to midsize pharmaceutical, biopharmaceutical, and medical device companies, advancing the development and registration of their products worldwide. Our highly qualified and passionate experts have deep experience in health authority interactions and in preparing complex regulatory submissions requiring specific and strategic regulatory expertise.

Project Management

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