Validation and Compliance Institute (VCI) www.vcillc.com, provides a full range of compliance services for FDA regulated industries. From submissions to process validation VCI can do the work for you, or train you to do it yourself. VCI writes INDs, IDEs, NDAs, 510Ks, PMAs, SOPs, and DMFs. 1) The easiest part of GMP compliance is learning the regulations. 2) Writing SOPs and training everyone is hard work. 3) But by far the toughest part is getting everyone to comply with the SOPs. Positive ComplianceTM from VCI gets you through this last step.