About HARQA
The Company
The Company
The Company
HARQA is a GCP QA consulting firm created with the objective of supporting Pharma and Biotech companies, and investigational sites in achieving audit plans and high quality standards by providing creative solutions.
Experience
The Company
The Company
More than 15 years of clinical research experience in the Pharma, CRO and Biotech industry, 13 of them in GCP QA, over 100 audits conducted globally.
Services
The Company
Services
Services tailored to client's needs. From auditing and consulting to training and monitoring, a range of options can be designed to support GCP quality operations.
About Us
After many years working in clinical research at Pharma, Biotech, CRO and consulting firms, HARQA Consulting LLC was created to offer clients more creative, flexible and adaptative solutions.
Experience
Diverse GCP audits
- Investigator Site Audits (ISAs)
- Process Audits (incl. QMS Assessment and gap analysis)
- Vendor audits including CROs, CSV and other service providers
- Trial Master File (paper and electronic)
- Phase I qualification
- Preparation of sites and sponsors for upcoming regulatory inspections and mock inspections
Global auditing
Audits conducted in the US, and in different countries all over Europe and South America, resulting in a unique global experience plus the flexibility that global audit program needs.
Unique combination of knowledge and experience
Our strength relies on the know-how gained by being exposed to a variety of audit types, QA and monitoring roles and geographical regions. This allows us to understand client's challenges and provide a solution that is both, adapted to their needs and of high quality standards.
We see auditing as an integrated way of accompanying the improvement cycle at the companies, and we consider it a continual exercise rather than a static activity.
Services
GCP Auditing
Education and Training
Remote audits
From auditing of clinical sites to qualification and assessment of CROs and other service providers, from assessment of Sponsor's QMS to auditing of the internal processes.
Remote audits
Education and Training
Remote audits
In times when moving around is not possible or a reduced budget is needed, remote auditing is a feasible option for ensuring compliance with companies' audit program and quality standards.
Education and Training
Education and Training
QMS creation and SOP writing
Whether one-on-one or group, face to face or virtual, different types of GCP related trainings can be created and delivered tailored to companies' needs.
QMS creation and SOP writing
QMS creation and SOP writing
QMS creation and SOP writing
Provide support in assessing and creating the QMS, working in collaboration with companies in optimizing processes and writing and implementing the necessary SOPs .
GCP Consulting
QMS creation and SOP writing
Audit Management
Provide support with identifying gaps and help companies and teams implement and improve processes that are specific and customized to their needs.
Audit Management
QMS creation and SOP writing
Audit Management
Support the QA and Operations teams with designing, implementing and executing audit programs.