We can evaluate your facility, documentation and operations to identify areas of risk with respect to regulatory requirements.
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.
We can ensure that your suppliers meet your requirements.
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
Our experience in the design and construction of cGMP facilities can assist you prior to construction to avoid compliance issues during later inspections.
Scott M Wheelwright PhD
BioInno Chief Operating Officer (COO)
- Internationally known quality expert
- Biopharmaceutical expert
- Co-founder of Innovent Biologics
- Founder of Comply Asia and BioInno