CMC Launch Program Management
Today’s global program strategies face enrollment, regulatory scrutiny, pricing/access, and competitive challenges. Great operational launch plans can ensure strategies are in place to mitigate CMC challenges and keep your global program leads focused on what matters most.
Launching rare or oncology programs from Phase II can bring CMC maturity into sharper focus. Establishing a risk-based approach with post-marketing plans becomes vital for your global program team.
CDMO/CMO Relationship Management
Companies large and small relying on contract development and manufacturing organizations experience ups and downs with their relationships. Implementing phase-appropriate processes between the organizations can ensure that agreements and statements of work are in place, that transparency and accountability come to the forefront, and create shared success for the program.
Global Markets
Navigating GxP requirements to access global markets presents a tough challenge for pipelines and life-cycle management. Asking questions about zone IV stability, drug product validation timing, shipping validation, regulatory sample requirements, and more can help avoid costly delays to your program, driving more value for your assets.
Put direct experience in all major markets, over eighty worldwide, to work for you by reaching out today
Supply Chain Architecture and Risk Management
Laying out a supply chain for launch is a start; setting out a flexible supply chain evolution is a game-changer. Each phase of an asset’s lifecycle brings challenges to capacity, supply chain resilience, tax exposure, sustainability, and more Devising a phase-appropriate architecture can ensure your therapy will be available when patients need it, that your company’s revenue streams be secure, and that environmental sustainability be considered at the start.