Help projects be delivered on time and within budget.
Programme Management oversees the entire lifecycle of a drug development project, from initial planning to final delivery with extensive experience, we effectively coordinate between internal GRA teams, clients, and external partners. Some key responsibilities include:
- Project Planning: developing detailed project plans, timelines, and budgets to ensure all activities are aligned with client expectations and regulatory requirements.
- Resource Requirements: recommending the necessary resources (e.g. personnel, equipment, materials) required to fulfil the project and allocate effectively throughout the project.
- Risk Management: identifying potential risks and implementing strategies to mitigate them, ensuring project continuity and compliance.
- Communication: maintaining clear and consistent communication with clients and internal teams to ensure alignment and address any issues promptly.
- Performance Monitoring: tracking project progress against milestones and key performance indicators (KPIs) to ensure timely and successful completion.
- Reporting: providing updates to all from bench to board with metrics agreed in advance.
At GRA, we excel in Contract Development and Manufacturing Organisation (CDMO) management. This ensures that drug development and manufacturing processes are executed efficiently and meet the highest quality standards. Our expertise spans managing both small and large-scale CDMOs across various jurisdictions, ensuring compliance and excellence in every project.
- CDMO Selection: identifying and selecting the best CDMO partners based on their capabilities, expertise, and alignment with the client's development goals.
- Contract Negotiation: assisting in negotiating contracts with CDMOs to ensure favourable terms and clear expectations.
- Technology Transfer: overseeing the transfer of technology and processes from the client to the CDMO to ensure seamless integration and execution.
- Quality Management: implementing robust quality management systems to ensure that CDMO activities comply with Good Manufacturing Practices (GMP) and regulatory standards.
- Performance Monitoring: continuously monitoring CDMO performance to ensure adherence to project timelines, budgets, and quality standards.
By leveraging GRA’s expertise, we help organisations navigate the complexities of programme and CDMO management, ultimately enhancing and accelerating the likelihood of successful drug development and regulatory approval.