HELPING YOU DESIGN YOUR PRODUCT DEVELOPMENT PROGRAM
Strategic and Tactical Product and Device Development
End-to-end strategic planning and tactics to improve time to market, control costs, plan timelines, and maximise the probability of successful regulatory approval.
Start-ups and small or medium-sized pharmaceutical, biotechnology, or medical device companies can sometimes lack the resources and time to build a detailed product or device development strategy.
Including a precise plan considering regulators’ needs (including special considerations such as accelerated regulatory approvals or incentives), risk and product/device category, market evaluation, and product/device USP.
Failure to create an end-to-end strategic plan can lead to unnecessary processes, project delays, management failures, unexpected costs, budget burdens, market failures, etc.
Whether your product/device is aimed at a broad and highly competitive market or a high-risk niche market, our experienced team can help you develop a comprehensive pharmaceutical product or medical device strategic development plan that will optimise efficiency, save time, control costs, plan timelines, and maximise the probability of success and entry into the market.
Our Strategic Product/Device Development Services include:
- Life-cycle development strategy and management planning
- planning, writing and modifying as data emerges
- defining key go/no-go criteria - Strategic licensing to boost growth or broaden development pipeline
- assisting business development in-licensing arrangements
- assessing therapeutic areas/markets
- identifying attractive target partners - Target product profiling (TPP)
- critical in designing and developing high-quality products/devices that are fit for purpose and meet specific health-related goals
- using MIRS (message, issue, response, support) methodology, our TPPs support product development and facilitate discussions with regulators - Program and protocol development
- identifying key studies and synopses - Identification and management of external contractors
- leveraging our professional network and experience, we help you appoint experienced consultants to manage deliverables
Our Tactical Product/Device Development Services include:
- Providing overall development programme advice, including the leadership of the pre-clinical development and clinical development teams
- Drafting Clinical Development Plans (CDPs) and providing oversight of clinical, pre-clinical and Chemistry, Manufacturing and Controls (CMC) development
- Non-clinical and clinical project team management and study management, study design and protocol writing, monitoring (including co-monitoring), and auditing
- Preparation of clinical documentation, e.g. Investigator Brochure (IB), Clinical Trial Authorisation/Application (CTA), Investigational Medicinal Product Dossier (IMPD)
- Act as project leader/project manager, including day-to-day oversight of European contractors
- Advising on the identification of a Contract Research Organisation (CRO)
- Setup and management of Data Safety Monitoring Board (DSMB) or Data Monitoring Committee (DMC)