GxP Quality Services
Our quality services can flexibly support a vast assortment of policies, processes and procedures for planning and execution, allowing your organization to identify, measure, control and improve your core processes that will ultimately lead to improved business performance. We are aiming at providing an integrated solution, with a fixed time scale and related standards.
Our team draws on their in-depth knowledge of FDA and worldwide GMP/GLP/GCP regulations to assure the deliverables meet the highest standards and fully comply with all regulations.
Design of Integrated Quality Systems to provide a process approach for project execution
Inspection readiness and coordination
cGXP compliance (quality systems, SOPs, record keeping)
Corrective action planning (CAPA)
Vendor and third party assessments and audits
Reviewing SOPs, preparation of documentation and guidance for implementation
OOS investigation (root cause analysis)
Monitoring quality systems
Performing gap analysis
Conducting internal audits (focus on risk mitigation)
Change control
Pre-FDA compliance audits
Coordinating clinical trials (pre-trial and site initiation monitoring, study monitoring, regular site compliance audits, trial close-out)
Developing and authoring clinical study related documents (informed consent forms, case record forms, SOPs, case report forms, protocols, amendments and deviations, study reports, non-clinical section of the Investigator’s Brochure)
Preparing Certificates of Analysis
