Helping You Meet Regulatory Compliance Expectations
Any firm associated with regulated activities such as clinical studies, manufacturing of pharmaceutical products or medical devices, production of raw materials, or laboratory services requires routine inspection and GxP audits. Pre-approval inspections are a large part of inspections and your license to operate and commercially manufacture products.
Such companies are expected to be compliant and continuously improving. As your partner, we can maintain alignment with new, existing, and changing regulations and industry standards that evolve throughout the drug product and device lifecycle.
Global Expertise Across the Regulatory Spectrum
Our team of specialists includes former FDA inspectors and CQA certified auditors who are proficient in conducting mock inspections, internal audits, vendor and supplier auditing, and gap assessment services. We serve as an extension of an organization’s Quality Department with respect to vendor and supplier auditing or act as a mock regulatory agency representative with respect to preparing your organization for an agency inspection. Partnering in a constructive and collaborative manner, we work together to understand, identify, and evaluate systems for quality improvements.
Our large network of compliance consultants covers the globe and has broad knowledge across the regulatory spectrum (GMP, GCP, GLP, GPV, GDPR, Med. Dev., CSV, DI, etc.).
Computer System Audits
We provide guidance on how computer systems should be validated to meet cGMP requirements and/or provide highly independent audits to assure your computer software vendors also meet the requirements to ensure a GMP validated system.
General cGMP Compliance Audits
We provide cGMP Compliance Audits to you on a one time or annual basis. We conduct highly independent and impartial audits and provide reports to you with suggestions for improvement.
Quality Systems Review
Compliance to GMP can only happen if there is a strong and well-defined Quality System. Unfortunately, with the ever-changing legislative requirements, it is not always easy to maintain a Quality System that meets the current requirement. Through the use of our services we can ensure that your Quality Systems not only meet current requirements, but are prepared for any new requirements that are currently going through the Regulatory consultation process.
Specialized Inspection Preparation Services
We can assist by undertaking a pre-approval inspection or mock inspection and gap analysis prior to the inspection by the regulatory agency. Our team of auditors have experience of over 60 regulatory inspections undertaken by various agencies including the MHRA (UK), HPRA (Ireland), EMA, SUKL (Czech Republic), FDA (US), Korean FDA, Turkish MOH, MCC South Africa, Anvisa Brazil, at sites in Argentina, Bangladesh, Czech Republic, England, India, Nordics, Belgium, Germany, The Netherlands, Switzerland, and Ireland.
We offer services such as:
- Conducting pre-approval regulatory inspections in all areas of GxP
- Conducting mock regulatory inspections in all areas of GxP
- Provide guidance on corrective actions to be implemented and validated prior to the regulatory inspection. This will give you the opportunity to rectify any issues prior to them being cited as regulatory non-compliances by the inspector
- Provide training on how to prepare for a successful regulatory inspection, including mock inspection interviews and the ‘Do’s and Don’ts’ of hosting and interacting with regulatory agencies
- Inspection readiness reviews – especially important now that unannounced inspections are becoming more frequent
- Reviewing level of compliance with best practice standards with a view to applying for, renewal or retention of the necessary appropriate licenses, such as MIA, WDA, MA, GMP, and GDP