compliance assessment / advice
The Compliance Group assists and advises companies on compliance with established international standards of GMP, GDP, GVP, GCP and Regulatory Affairs. We review general compliance levels or focus on specific issue(s) of concern and advise on potential solutions.
Where the issue requires notification to Regulatory Authorities or has arisen as a result of engagement with the Authorities, we can provide advocacy for our customers, either in the background or in the foreground.
In addition, the depth of experience of our consultants at technical and administrative levels within the IMB, now the HPRA, uniquely positions The Compliance Group to provide training and advice to regulatory authorities who supervise the regulation of medicinal products. Our consultants can provide in-house training in inspection and can provide off-site advice on an ongoing basis.
Mock inspections are a speciality of The Compliance Group. Mock inspections are generally performed on an “in-mode / out-of-mode” basis to:
- assist a company to prepare for inspections by regulatory authorities,
- implement or improve self-inspection programmes,
- stress test systems and personnel within safe environment,
- improve staff confidence in relation to regulatory inspections.
We offer these inspections to EMA standard using ´normal rules of engagement´ at full scale or at a reduced scale focusing on specific areas of concern.
The mock inspections can be performed in the areas of GMP, GDP, GVP, GCP and Regulatory Affairs (for MAHs).
Our compliance clinics are efficient systems in providing specialised consulting for different departments within the same organisation.
Appointments are made with individual departments to discuss topics of interest. Typically the appointments range from 30 to 45 minutes.
“We have a problem” – this is how many of the phone calls we receive from new customers begin. Due to our experience as Regulators, we are familiar with many problems that companies have encountered, and more importantly, the typical manner in which companies have navigated themselves out of difficulty.
We are often recommended by word of mouth to companies who find themselves experiencing Regulatory Distress for the first time, such as where Critical Deficiencies have been issued following inspections relating to Marketing Authorisations, Pharmacovigilance and Good Manufacturing Deficiencies. On certain occasions, part of the corrective action proposals to the Regulatory Agencies is that they have engaged the services of The Compliance Group.
We have a 100% success rate in guiding companies out of Regulatory Distress.
We are available to provide due diligence assessments for companies seeking to acquire a pharmaceutical / pharmaceutically related company. The unusual nature of the due diligence rules of engagement mean that we can quickly verify likely compliance or identify potential areas of concern.