Gap Analysis We can evaluate your facility, documentation and operations to identify areas of risk with respect to regulatory requirements. Inspection Readiness Our experts have been through EMA and FDA inspections; we can assist you in preparing for inspections by regulatory authorities, by clients, and by partners; we can also perform mock inspections. Vendor Audits We can ensure that your suppliers meet your requirements and those of regulatory agencies. CMC (Chemistry, Manufacturing and Controls) We have experience in preparation of INDs, NDAs and BLAs. We can help you manage your contract manufacturing and testing organization projects. Operations Support and Improvement Our trained specialists can supplement your in-house staff when you face special needs, including reviewing batch records, reviewing validation protocols and reports, providing technical translation of documents, or serving as QA person-in-the-plant during operations. Facility Review Our experience in the design and construction of cGMP facilities can assist you in avoiding compliance issues during later inspections. We recommend a compliance review of the facility plan during the conceptual design stage.