Successful programme and project management of biopharmaceutical, pharmaceutical, healthcare, over-the-counter (OTC), and medical device products requires a unique blend of technical, scientific, regulatory, and quality skills to ensure focus and delivery of those critical activities that will directly impact the product registration and approval.
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 blend of skills within their own resource pool to manage this complex blend of activities.
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Woodley BioReg has extensive scientific, healthcare, and pharmaceutical sector expertise and can provide leadership to a project team. We have supported biopharmaceutical projects through early pre-clinical development, clinical development, process development and validation, and product licensure. Our remit includes agency interactions, meetings for scientific advice, and IND submissions.
WBR has also managed the regulatory and submission process by providing the interface between all stakeholders and departments — including third party manufacturers — and regulatory agencies.
WBR has 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 with cGMP.
Woodley BioReg’s project managers are highly skilled and experienced, with in-depth understanding of all aspects of the entire drug development process. We significantly enhance our client’s projects by providing support, including:
- 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
- Ensuring the project team are focused on a common set of objectives
- Ensuring project objectives and deliverables are met on time and in full
- Provision of meaningful project metrics