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.

GxP Consultancy Service Capability includes:

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.

  • General GMP
  • General GLP
  • Inspection Readiness
  • Contract Manufacturing Organizations
  • Contract Laboratories
  • Computer System Suppliers

Quality Systems

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

  • Product Stability Programs
  • Method Validation Programs
  • Lab Compliance

Work Order Generation and Tracking

  • Supplier Certification
  • Raw Material Specification
  • Warehousing - Quarantine through Release with Traceability
  • We can set up a process validation program ranging from writing of SOPs and Master Plans to writing and executing the protocols and summarizing the data into usable reports.
  • Cleaning processes
  • Computer systems
  • Plant/Facility Equipment
  • Analytical Lab Equipment
  • Investigations and Corrective Actions
  • Document Review and Approval
  • Lot Dispositioning
  • 21 CFR regulations Part 11 Electronic Records Compliance
  • GLP/cGMP or GCP Training
  • Part 11 Training

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.