Flexible API, pharma and biotech auditing services.Increase control over your supply chain. Worldwide auditing services in GMP, GDP, GLP and GCP.
For Pharma & Biotech
We perform audits of suppliers and contractors in the pharmaceutical industry. Our auditing services are worldwide and cover every major regulatory framework.
Auditing services include; coordination with the auditee, audit preparation, audit execution (on-site or remote) and reporting.
Outsource your audit to PCS, we usually respond within the hour!
We have the expertise and experience to perform your GxP audits worldwide!
We usually respond within 1 hour or working day!
Auditing pharmaceutical manufacturers, importers or contract laboratories against the GMP's.
EU, WHO or U.S. FDA.
Auditing warehouses and distributors of medicinal products against the GDP's.
Auditing pharmaceutical laboratories and contract laboraties against the GLP's.
EU or U.S. FDA.
Auditing clinical trial providers against the GCP's.
EU, WHO or FDA.
PCS has a large team of qualified GxP auditors. With extensive experience in running international audit programs. We have organized and executed corporate audit programs for a number of multinationals like Sandoz, Novartis and Norgine International.
Our experience makes us the ideal partner to outsource your audit program to. PCS' international scope allows us to be flexible, fast and deliver high quality audit reports. During COVID-19 we can perform audits on any continent or country, requiring only local travel.
We audit any type of pharmaceutical supplier, including (but not limited to); excipients, active pharmaceutical ingredients, laboratories, distributors, warehouses, laboratories and software providers. Our expertise lies primarily with the EU/WHO or U.S. FDA GxP's. Other international standards like IPEC, EXCiPACT, ISO 13485 and PIC/S can also be audited against.
Our audit solutions are flexible. You can outsource any number of audits or your entire supplier qualification program to PCS.
Whether it's a private or shared audit, our experienced auditors will ensure flawless execution and reporting. We can also train your auditors on auditing best practices or qualify your auditors.
PCS has been organizing audit training since 1993. We can train individual auditors or corporate auditing teams.
If required, PCS can qualify you auditors. We have organized qualification training sessions for the global audit teams of Novartis and SunPharma.
We perform mock audits of companies to prepare for regulatory inspections or client audits.
The mock audits can be performed against the EU GMP, WHO GMP or U.S. FDA GMP. During the mock audit, and the preparation, the auditor(s) will not only make observations but make recommendations for improvement as well.
Because we make recommendations during the audit, your staff is able to define better and more accurate CAPA's.