Our capabilities encompass all aspects of a development program for a drug, biologic, or medical device, including strategic development planning; project management; regulatory (FDA liaison and communication; preparation of regulatory submissions); nonclinical (preclinical protocol design, management, and analysis); chemistry, manufacturing, and controls (CMC); clinical (protocol design; site selection; investigator contracts; site monitoring; medical and safety monitoring; data management and biostatistics; medical writing); quality systems (GCP/GLP/GMP audits); SOP development; vendor contracts, and financial project accounting.

Nonclinical Planning

RRD’s consultant toxicologist works with the team in the design and execution of the overall nonclinical safety program.

Regulatory Planning

RRD works with our clients in the design of the overall regulatory program. We carefully consider how to position the product with regulatory agencies and, ahead of any interactions, evaluate the regulatory issues that the regulatory agencies might have and develop a plan to mitigate/manage any potential risks.

Clinical Planning

RRD, along with the company and clinical advisors, will design an overall clinical program that will support the desired label and build value in the product. In addition, the program must be consistent with the company’s business objectives, such as providing early proof of mechanism data to support further development, potential partnering, and/or fundraising.

CMC Planning

RRD works with our clients and/or contract manufacturers to integrate the manufacturing strategy into the overall development plan and project management activities.

Core Quality Systems Support

RRD has an internal quality system to assure compliance with all applicable regulatory requirements based on the scope of the program. In addition, we can assist our clients in designing a broader quality plan consistent with the company’s needs and stage of development. These plans include SOPs to cover key corporate regulatory responsibilities, as well as high-level development processes and procedures within the company including selection, qualification, and management of development service vendors.

General and Administrative Support

RRD also can provide project accounting and vendor contracting support for product development programs, as needed.