Program Management

BioProcess Technology Consultants offers comprehensive and dynamic project planning and management services to keep your development and commercialization programs on time and within budget. Our team can help you integrate all of your product development requirements into comprehensive playbooks that provide a seamless roadmap for efficient management of your product development programs from the initial identification of a new product candidate through clinical trials and commercialization.

Using these playbooks and other project management tools and guidelines, our consultants effectively manage all aspects of your day-to-day CMC requirements, helping you:

  • Develop target product profiles that incorporate the desired quality and performance aspects of your product
  • Prepare and manage product development plans and timelines that clearly show all required activities and key milestones along with their interdependencies
  • Manage both external and internal development programs for process development, analytical methods development, manufacturing and QC testing and release
  • Perform risk analyses to evaluate multiple scenarios for development or manufacturing and assessing overall product supply chains
  • Implement the best development and manufacturing solutions for accelerating development timelines and product commercialization while controlling risk
  • Select and manage outside service providers and integrate your outsourced programs with in-house activities

The BPTC PROMOTE™ service provides early-stage companies with in-depth review of development programs and data resulting in a detailed, comprehensive CMC strategy and plan tailored to the specific program. The Strategic CMC Development Plans are designed to provide a road map for meeting regulatory requirements as well as all product quality and process performance objectives within a specified budget and time frame.

For later stage programs we provide detailed evaluation and strategic planning of CMC commercial and regulatory strategies to guide you through the complexities of late-stage product development in anticipation of a successful product launch. We help develop and implement appropriate strategies, options, and decision matrices for the optimization and scale-up of your manufacturing processes, process validation, implementing Quality by Design, and ensuring development of an optimal product presentation to meet your desired product profile.