Flexible solutions for your compliance needs. LT Clinical Research assist and support client companies to achieve cGMP, GLP and GCP compliant quality management systems.
We ensure full compliance. Our teams of experts have successfully cleared numerous international regulatory audits for various global companies. They also have expert knowledge of the various international regulatory regimes: USFDA, MHRA, SA's MCC, WHO Geneva, BSG Germany, Korean FDA, HPFBI Canada and TGA Australia.
cGMP & GLP Auditing (Internal and External)
LT Clinical Research can perform all types of cGMP, GLP and GCP Audits and provide clients with a comprehensive report of recommended corrective actions, including full references to the pertinent regulations and guidance documents.
We can create, review and implement Quality Systems including those for QA/QC, Manufacturing, Laboratories and support group.
Tracking systems and follow up
Integration with document systems
Document formats and numbering and Issuance and Change Control
Master Plan, SOPs and Protocols
Work Order Generation and Tracking
Assist the CEO and Department Heads of communications regarding federal regulations and compliance issues
Source and implement custom designed electronic submission systems for regulatory authorities and agencies.