Programme and Project Management of biopharmaceutical, pharmaceutical and healthcare, over-the-counter (OTC) and medical device products requires a unique blend of technical, scientific, regulatory and quality skills. This ensures the project focus remains on those critical areas that will directly impact the success of the programme. Often the commercial success of a project depends on the effective management throughout the clinical, product development, commercialisation, and licensing stages. Many companies find they lack the skills within their own resource pool to manage this complex blend of activities.
How Woodley BioReg can help
Woodley BioReg have extensive scientific, healthcare and pharmaceutical sector experience and expertise and can provide leadership to a project team. We have supported biopharmaceutical projects through early preclinical development, clinical development, process development and validation, and product licensure.
We have overseen contract manufacturers through a “man in the plant” model to ensure that the contract manufacturer’s activities are planned, executed and documented, in accordance with the client’s objectives AND in compliance to cGMP. We have also managed the regulatory process by providing the interface between all concerned groups and departments, including third party manufacturers and regulatory agencies.
Woodley BioReg’s project managers are highly skilled and experienced, with in-depth understanding of all aspects of the entire drug development process. We can significantly enhance your projects by providing:
• Primary point of contact and effective flow of information
• Early identification of project risks
• Contingency and scenario planning
• Rapid resolution of issues
• Scope change management
• Resource management
• Maintenance of a highly effective project team who are flexible and responsive
• Ensure the project team are focused on a common set of objectives
• Ensure project objectives and deliverables are met on time and in full
• Provision of meaningful project metrics
For more information on Project Management please contact us.