We are a highly experienced in global drug, biologicals and medical device development for pharma, biotech, veterinarian, diagnostics and medical devices.

The last years  regulatory affairs and CMC has gained much strategic importance in specifically the decision making process of products in development and company strategy in general including geoexpansion.

To decrease time to market a good regulatory and CMC strategy and competitor analysis is needed. Strategy combined with good quality regulatory and CMC documentation and regular interactions with competent authorities will increase your chances of product registration and time to market.