Navigating The Regulatory Maze: Fundamentals for Drug Development
Navigating through the evolving regulatory landscape can be a challenge, especially for early-stage biotechnology companies developing a drug for the first time. The production process developed for new drug candidates is governed by a stringent and extensive set of requirements to which every manufacturer must adhere. Understanding and properly applying these regulations are critical to success and avoiding unnecessary delays.
The video series below provides basic regulatory knowledge all biotech start-ups need to successfully bring their molecule to market.
GMP vs. Non-GMP:
GLP:
ICHQ7:
GMP vs. Non-GMP:
GLP:
ICHQ7:
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