Global cGMP, GCP, GLP & GVP Auditing and Compliance Services
A global consortium of senior GxP professionals assisting pharmaceutical, biopharmaceutical and medical device industries to comply with GxP requirements and succeed in regulatory inspections.
Risk-based & Practical GxP Compliance Support
We are a global consortium of senior GxP professionals (with 25+ years of experience) specializing in inspection readiness, audits, and compliance strategy across cGMP, GLP, GCP & GVP. With extensive hands-on experience interacting with global regulatory authorities such as FDA, Health Canada, EMA, MHRA, PMDA, NMPA, MFDS, CDSCO etc., we help organizations prepare for a successful inspection and also assist in post-inspection interactions with the regulatory authorities.
We provide end-to-end support — from audit planning, readiness assessment, SME training, mock inspections, audits & CAPAs to CAPA closure and effectiveness verification — for pharmaceutical, biopharmaceutical, biotech, medical device, and CRO organizations.
End-to-End GxP Services for All Phases of Drug Product Development
Offered as standalone engagements or as a fully integrated program tailored to your pipeline, development phase and risk profile.
Quality Management Systems & Audits
Extensive experience developing and implementing phase-appropriate quality systems following Quality by Design principles for pharmaceutical, biopharmaceutical, and medical device industries.
- Develop client-specific QMS aligned to the unique needs of the program and phase of development
- Analyze existing QMS, identify gaps, and provide phase-appropriate and resource-efficient solutions
- Investigation, impact assessment, and resolution of deviations, OOS results, non-conformities, and process failures
- cGMP, GLP, GCP & GVP support
- QMS remediation to address gaps based on guidance and regulatory requirements
- Develop, execute & manage risk-based audit programs
- Internal, external, routine, and for-cause audits
- Clinical sites (Phase I–IV), CROs, CMOs/CDMOs, TMF, CSR, system/process audits, API suppliers, packaging/labeling, distribution, laboratories
- Vendor selection, qualification & oversight
Regulatory Affairs
End-to-end strategic and operational support for pharmaceutical/biopharmaceutical product lifecycle — from discovery through nonclinical, clinical, marketing authorization, and post-market commitments.
- Strategic & tactical regulatory assistance to meet global requirements across the product lifecycle
- Experience with FDA, Health Canada, EMA & National Competent Authorities, MHRA, PMDA, TGA, ANVISA
- Review & assess current status for Pre-IND, IND, CTA, BLA/NDA, information requests, responses to deficiencies/hold
- First-in-Human (FIH) readiness & BLA/NDA gap analysis
- Readiness of meeting requests, designation requests, and response submissions
- Lead/assist clients in internal preparation for regulatory meetings
- Meeting participation, minutes, and post-meeting communication with regulatory agencies
Inspections
Need-based solutions for preparation and management of regulatory inspections, and handling post-inspection communications across FDA, Health Canada, EMA, MHRA, PMDA, MFDS, NMPA, TGA, ANVISA, and CDSCO.
Preapproval Inspections · GCP, cGMP, GLP & PV Inspections · Clinical Sites / CRO / Vendor Inspections
- Review & evaluate current status to identify gaps/risks and recommend remediation
- Develop inspection readiness plan and timelines
- Training of functional SMEs
- Develop inspection playbook
- Oversight of CRO/vendor inspection preparation
- Plan & conduct mock inspections — simulate scenarios, interview SMEs, information requests
- Provide detailed Mock Inspection Report identifying deficiencies
- Collaborate with internal team to develop responses
- Manage / provide oversight for sponsor, clinical site, CRO/vendor inspections
- Actively participate in all inspection activities to ensure smooth conduct and timely, accurate responses
- Collaborate to develop, prepare, and review responses to inspection deficiencies before submission
- Manage corrective action implementation and track progress
Training
In-person or virtual training for cGMP, GLP, GCP & GVP compliance — tailored to your team's role, phase, and risk profile.
- Annual GxP Training
- Deviation & CAPA Management
- Any topic related to GxP compliance in drug product development
Nonclinical / Preclinical Development
Planning and execution support for nonclinical development programs to generate reliable, robust data supporting product development and regulatory submissions.
- Regulatory positioning & early interaction strategy
- Animal model selection & study design
- FIH planning & identification of minimum requirements
- Detailed roadmap & timeline
- Critical path identification
- Resource planning
- CRO / CDMO / vendor selection
- Write/review study protocols, reports & regulatory submissions for accuracy, completeness, and compliance
- Cross-functional CRO/vendor oversight, monitoring, and audits
CMC
Hands-on, phase-appropriate support for all aspects of CMC and drug product development under R&D and cGMP conditions. Develop, optimize, and validate effective, efficient, and cGMP-compliant manufacturing processes and analytical procedures.
- Facility assessment & design review for cGMP compliance
- Manufacturing process development & validation support
- Analytical method development & validation support
- Development of manufacturing records/documentation
- Product characterization and/or specifications
- Process characterization & risk assessment
- Technology transfer & scale-up
Clinical
Extensive expertise developing customised solutions to ensure the success of clinical trials — from document development through site close-out and quality assurance.
- Clinical protocol, Informed Consent Form, Investigator's Brochure, Study Manuals, Pharmacy Manual, Statistical Analysis Plan, SAE Forms
- Develop/review product labels for regulatory compliance
- Procedures for handling investigational products — shipping, storage, distribution, administration
- Management of product complaints
- Clinical site qualification, initiation, routine monitoring, and close-out
- Regulatory & ethics submissions
- Risk-based quality management & risk-based trial monitoring
- Electronic Data Capture development and management oversight
- Trial Master File set-up and management oversight
- Clinical Quality Assurance
Integrated Global GxP Support across three continents
Standalone engagements or fully integrated cGMP–GCP–GLP–GVP programs — compliance activities tailored to your pipeline, development phase and risk profile.
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