Our belief is that all product development has a regulatory purpose. RRG provides integrated strategic and project management services to support the efficient development of pharmaceutical products from inception right through to marketing authorisation – helping you to execute your product development plan to achieve regulatory and commercial success.
A different approach to virtual product development
- Our approach focuses on the central importance of an effective team to steer the project and the execution of the project plans, to review progress and make key decisions to ensure a successful outcome. This is particularly critical in projects where there is significant out-sourcing in a virtual development approach.
- RRG can provide regulatory, clinical, non-clinical and CMC expertise to an existing project or take on the role of project leader in setting up and managing a core team from scratch.
- RRG has access to a wide network of companies and individuals that are able to contribute to the project team delivering high quality services to companies that contract out their development activities. The network includes analytical, contract manufacturing, QA/GMP, non-clinical and clinical, data management and statistics service providers.
RRG can use this approach and network of contacts to help support the drug development programme in a flexible, integrated way, responsive to the individual client's needs.
At each stage of development, RRG can provide:
- Strategic planning
- Project management
- Assistance with CRO selection and management of CRO interaction
- Protocol design and writing
- Preparation of study documentation - investigators' brochures, study reports
- Preparation of ethics submissions and liaison with ethics committees
- Full management of early phase clinical studies
- Provision of clinical trial monitors and auditors
- Assistance in the development of a Quality Management System to support GCP requirements and inspection
- Training on GCP and responsibilities of Sponsors
- Submission of regulatory applications
- Coordination of scientific advice
The integration of these services with our regulatory strategy and regulatory submission offerings ensures a coordinated approach to the implementation of your product development plan.