Compliance consulting

We provide PIC/s GMP compliance advice that is based on cost-effective and practical compliance, not just compliance without regard to business demands.

We consult and train on regulatory GMP compliance, product registration, validation and continuous improvement of manufacturing processes.

CiPharma’s consults to those industries subject to¬† European (EMA), U.S. (FDA) and Australian (TGA), drug and medical device regulations.

CiPharma’s team includes international GMP experts and consultants who previously held leadership roles within regulatory bodies.

Compliance strategy development

GMP compliance advice that is based on cost-effective and practical compliance, not just compliance without regard to business demands.

GMP mock audits

Called ‘GMP Mock Audits’, ‘Pre-audit Audits’, ‘GMP Gap Analysis’ or ‘Pre-regulatory audits’, a GMP Compliance Audit is conducted by someone external to your organization with the purpose of discovering GMP deficiencies.

Part 11 / Annex 11 compliance consulting

If you are implementing a computer system and want advice on if it needs to be compliant to the 21 CFR Part 11 electronic signatures regulation and how to achieve this, we can help.

Audit findings responses

If you’ve received an audit report and now need to prepare your response, we can help you achieve the best outcome.

QMS consulting

If you are setting up a new QMS or yours is inadequate, our consultants can advise you on the best way to structure, implement and maintain a QMS.

Supplier / Vendor audits

If you are struggling to keep up with auditing your suppliers we offer a supplier audit service, including an economical shared audit service.

Facility design review

Will your new or upgraded facility meet the GMP requirements of all the countries you supply to?