MF BIOTECH specializes in providing strategic project leadership and consulting for innovative biopharmaceutical development projects. They offer comprehensive support in the areas of global development strategy and regulatory affairs.

• Establish an integrated and tailor-made development strategy for your biopharmaceutical product.
• Develop functional and technical development plans including key milestones for CMC, non-clinical, clinical, and regulatory.
• Assess options to accelerate product development.
• Lead and manage development programs, projects, and portfolios, including planning and tracking timelines, quality, and costs.
• Plan and execute tech transfer projects.
• Prepare and manage scientific advice meetings and regulatory interactions, including documentation and procedures (EMA, FDA, Health Canada).
• Authoring of IMPD, IND, MAA, NDA, BLA.
• Authoring of requests for ODD and PIP.
• Prepare requests for expedited regulatory programs such as PRIME, breakthrough, RMAT designation.