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Pharmaceutical companies are challenged to adapt to market needs while also managing evolving and intricate supply chains. They must comply with the regulatory requirements of the FDA to include 21 CFR Part 11Electronic Records; Electronic Signatures to ensure that signatures are reliable and equivalent and the associated records are trustworthy. Additionally, compliance has to be observed related to the manufacture of pharmaceuticals contained in 21 CFR Parts 210 and 211.


We utilize proven methodologies and best practices to deliver in-depth regulatory expertise globally in the following areas: