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Drug Development Assessment | Product Development | Project Management

RPI offers full-service strategic and tactical regulatory expertise in all phases of drug development to companies of all sizes ranging from early-stage startups to some of the world’s largest life science companies. RPI’s team of experts leverage our comprehensive submission experience to strategically position and guide clients through a streamlined and customized approach to 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

Provide an independent assessment of development program
Assess regulatory precedence and landscape, and make recommendations on most efficient path to meet development milestones
Identify critical path items early and devise risk management solutions with no/minimal impact
Provide experienced resources to lead/assist in managing programs via established processes and reporting
Provide targeted support to remediate distressed programs and get them back on track

Product Development

We offer full service strategic and tactical product development expertise in all stages of drug development. We provide product development advice and tactical guidance grounded in decades of experience.

Sponsor can leverage our teams’ decades of experience
Sponsor can rely on our dedicated team in your project
Delivery

Strategic Product Management and Tactical Planning

Management of strategic planning and coordination cross functional teams to accomplish corporate objectives
Project management leadership providing strategic input on development plans and identification of the most efficient path to meet development milestones
Devise risk management solutions to critical path issues
Provide experienced resources to lead/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 mid-size pharmaceutical, biopharmaceutical, and medical device companies, advancing the development and registration of their products worldwide. Today, we are a highly-qualified and passionate team of experts with deep experience in health authority interactions and in the preparation of complex regulatory submissions requiring specific and strategic regulatory expertise.

Project Management

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Drug Development Assessment | Product Development | Project Management

Strategic Drug Development and Planning

Product Development

Strategic Product Management and Tactical Planning

Headquarters

North Carolina

San Diego

United Kingdom

Australia