Homepage divide Contact us
LT  image

GxP Consulting Services

Flexible solutions for your compliance needs. LT Clinical Research assists and supports client companies to achieve cGMP, GLP and GCP compliant quality management systems.


We ensure full compliance. Our teams of experts in this regard 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.

gxp image


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

Equipment 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


Change Control

  • Integration with document systems

Document Control and Retention

  • Document formats and numbering and Issuance and Change Control

Environmental and Utility Monitoring

  • Master Plan, SOPs and Protocols

Laboratory Control

  • Product Stability Programs
  • Method Validation Programs
  • Lab Compliance

Maintenance and Calibration

  • Work Order Generation and Tracking

Materials Management

  • Supplier Certification
  • Raw Material Specification
  • Warehousing – Quarantine through Release with Traceability

Process Validation

  • 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

Quality Assurance

  • Investigations and Corrective Actions
  • Document Review and Approval
  • Lot Dispositioning
  • 21 CFR regulations Part 11 Electronic Records Compliance

Training and Development

  • GLP/cGMP or GCP Training
  • Part 11 Training

Executive Management Support

  • Assist the CEO and Department Heads of communications regarding federal regulations and compliance issues

Electronic Regulatory Submissions Management Solutions

  • Source and implement custom designed electronic submission systems for regulatory authorities and agencies.


find us on google maps
All Rights Reserved - LT Clinical Research (Pty) Ltd. - 2012.
All intellectual property rights are reserved. The reproduction of any text, graphics, images, films or sound files, code, design or logo for commercial purposes is forbidden without written permission. We use reasonable endeavours to ensure that the information given on our website is accurate. We do not however make any representation about the information’s accuracy or completeness. We cannot accept any responsibility or liability for any loss or claim arising, directly or indirectly, from any error or inaccuracy in any of the material on our website.