That's all a part of design control, and it is common among regulated industries (US and abroad). It's not hard to do, it just takes some diligence. As far as

That's all a part of design control, and it is common among regulated industries (US and abroad). It's not hard to do, it just takes some diligence. As far as the biotech industry, the funding situation is awful, especially for early companies, and that is a fine reason to avoid this area. Needing to "say what you do and do what you say" doesn't strike me as that much of an obstacle in comparison.