Mock Inspections
One of our standout services is our mock inspection and inspection readiness programme.
Leveraging our expertise as former employees of the FDA and various national healthcare authorities, we have a unique ability to simulate FDA inspections. This process allows us to identify and address potential issues and concerns before they trigger an FDA Form 483 or FDA Warning Letter.
Our services extend to ensuring FDA inspection readiness through the conduct of mock inspections. These simulations encompass your plant or facility, as well as third-party facilities, vendors/suppliers and contract manufacturers and laboratories.
A mock inspection conducted by our team will prepare you for the intricacies of an actual FDA or other health authority inspection. We can offer guidance on best practices and communication strategies, document and record presentations and task delegation across various facets of the FDA inspection.
Trusted by top-tier teams worldwide
We have experience conducting mock inspections with the following authorities:
- FDA (USA)
- MHRA (UK)
- EMA (EU)
- Health Canada
- TGA (Australia)
- Swissmedic (Switzerland)
- ANSM (France)
- PMDA (Japan)
- CDSCO (India)
- NMPA (China)
- ANVISA (Brazil)
- SAHPRA (South Africa)
- HSA (Singapore)
FAQs
At Apotech, we offer full transparency on our Quality Assurance services. We aim to make the process as simple to understand as possible and are always on hand to answer any questions you might have.
Here are some of the questions we get asked most often.
Yes, we have an amazing team of consultants who work with us to perform local activities such as batch release or authoring SOPs in local languages.
As we understand each country's specificities, we can supply you with the right qualified person, according to the local regulations required.
Featured case studies
GMP QA Consulting
GMP QA Consulting Introduction Global API Manufacturer The client was an API manufacturer, with a need for some support to cope with a deviation backlog. Apotech consultant: Two QA Consultants, with backgrounds in sterile devices. Types of Audits GMP Tools: Ishikawa, 5M Audit Locations Europe Scope of work Under the QA director supervision, our consultant…
Batch Release as EU Qualified Person
Batch Release as EU Qualified Person Introduction Our client is a vertically integrated company in chemical synthesis and manufacturing of generic Active Pharmaceutical Ingredients and Drug Products. Standards and references cGMP ISO 9001 GDPR Trackwise, World Excel, power point Scope of work Remote batch certification and release of medicinal products Provide regulatory expertise as…