Global Development Strategy & Regulatory Affairs

MF BIOTECH specializes in providing strategic project leadership and consulting for innovative biopharmaceutical development projects. We offer comprehensive support in the areas of global development strategy and regulatory affairs. Our expertise spans a wide range of biopharmaceutical products including CAR-T, genetically modified organisms, mRNA, protein-based drugs, and bacteriophages.

• 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.