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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.

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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.


Auditing

  • 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


Qualification

  • 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.

 

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