GxP Compliance: auditing
The QARP aids and advises biotechnological, pharmaceutical companies, CROs, and other healthcare organizations and laboratories involved in drug development on GxP and Regulatory Affairs compliance with established worldwide standards.
The obligation to conduct internal audits or external evaluations of major services and as well as material suppliers has become a fundamental motivator for regulatory compliance and corporate governance within the Pharmaceutical Sector.
We assess overall compliance levels or focus on specific issues of concern and offer recommendations based on our broad experience.
Our experts have performed over 500 audits in EU, EAEU, CIS,
and Latin America countries.
The obligation to conduct internal audits or external evaluations of major services and as well as material suppliers has become a fundamental motivator for regulatory compliance and corporate governance within the Pharmaceutical Sector.
We assess overall compliance levels or focus on specific issues of concern and offer recommendations based on our broad experience.
Our experts have performed over 500 audits in EU, EAEU, CIS,
and Latin America countries.
The QARP capacity includes but not limited to conducting audits of:
- Investigator Site
- Sponsor and/or Investigator File
- Contract Research Organisation
- Pharmaceutical warehouse
- Computer Systems Validation
- Logistics company
- Local and analytical laboratories
- Data management processes
- Preclinical study site
- Medical writing, etc.
The QARP project is ready to help you and to perform online audits worldwide of, for example:
- Trial Master File
- Contract Research Organisation
- Logistics company
- Local and analytical laboratories
- Medical writing, etc.
When prepared correctly, the format of audit performance can optimise expenses and time necessary for an audit
Preparation for an inspection
The QARP experts have a unique experience of participation in inspections by international regulatory authorities (e.g. FDA and EMA inspections and etc.).
We are ready to help you with preparation of
a study site/organisation for an inspection with regards to the requirements of national and foreign regulators, as well as, to support methodically document flow during
the inspection period.
We are ready to help you with preparation of
a study site/organisation for an inspection with regards to the requirements of national and foreign regulators, as well as, to support methodically document flow during
the inspection period.
Our team
- Maxim BunimovichIndependent international GCP auditor
- Onsite and Remote Good Clinical Practice audits (Investigator Site Audit, Trial MAster File, Phase I units, CRO vendor and etc)
- Inspection Preparation assessments and Mock inspections
- Medical Device audits (ISO14155)
- Quality Management System consulting
- Good Clinical Practice training and etc
- Alena KulikovaExpert, independent auditor and trainer in Good Clinical Practice, The QARP
- Onsite and Remote Good Clinical Practice audits (Investigator Site Audit, Trial MAster File, Phase I units, CRO vendor and etc)
- Inspection Preparation assessments and Mock inspections
- Good Clinical Practice training and etc
- Polina GremyakovaThe QARP Expert in Good Clinical Laboratory Practice
- Good Clinical Laboratory Practice audits (e.g. Central and Analytical laboratories)
- Good Laboratory Practice audits
- Paul MacMahon, RQA
- Onsite and remote Investigator Site Audits and Trial Master Files audits
- Onsite and Remote Vendor Qualification audits in Good Clinical Practical and Good Clinical Laboratory Practice Audits (e.g. Central, Bioanalytical and Specialist), archives, ePRO, Central Imaging, CRO , Phase I, Translation Vendors, TMF Management, IMP Depots, IXRS providers)
- Sabrina Dey
- Onsite and Remote Good Clinical Practice audits (Investigator Site Audit, Trial MAster File, Phase I units, CRO vendor and etc)
- Inspection Preparation assessments and Mock inspections
- Medical Device audits (ISO14155)
- Quality Management System consulting
- Good Clinical Practice training and etc
They trust us
Contact us
THE QARP
info@theqarp.com
Ul. Adama Branickiego 21 U3
Warsaw; Mazowieckie;
Postal Code: 02-972
Warsaw; Mazowieckie;
Postal Code: 02-972