GxP Consulting Services

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

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.