Zymo can assess your needs and help you get to the next stage: whether it is to file your first IND, develop and/or manage your Phase I-III trials, or set up FDA meetings for each stage of drug development.
The clinical development plan describes the pathway for a company to translate the goals of an initial product profile into the clinical studies that will define the final indications and labeling for the product. The plan is a living document that is updated regularly to reflect new data.
Navigating through today’s complex regulatory environment requires the skill and experience that Zymo can provide. We have worked successfully with multiple FDA divisions at every stage of product development from pre-IND submissions to NDA/BLA filings.
Zymo Consulting Group has provided strategic planning for large and small biopharmaceutical companies. We help you set goals, establish timelines, estimate costs, and create scenarios.
