We can evaluate your facility, documentation and operations to identify areas of risk with respect to regulatory requirements.

Gap Analysis

Inspection Readiness

Our experts have been through many inspections by EMA and FDA inspectors, we can assist you in preparing for inspections by regulatory authorities, by clients and by partners, and we can perform mock inspections.

Vendor Audits

We can ensure that your suppliers meet your requirements.

Training

Our experienced specialists can provide specialized and general training in Quality Systems, documentation, cGMP operations, and inspections or audits.

Our trained specialists can supplement your in-house staff when you face special needs, including review of batch records, technical translation of documents, or serving as QA person-in-the plant during operations.

Operations Support and Improvement

Facility Review

Our experience in the design and construction of cGMP facilities can assist you prior to construction to avoid compliance issues during later inspections.