In today’s highly regulated pharmaceutical and life sciences environment, regulatory compliance is an ongoing responsibility—not a one-time activity. Our Compliance Support services help organizations build, maintain, and continuously improve systems that meet GMP/GxP, CDSCO, and global regulatory requirements.
We provide practical, hands-on compliance support that ensures inspection readiness, strengthens quality systems, and minimizes regulatory risk across the product lifecycle.
End-to-End Regulatory & GMP/GxP Compliance Support
Our compliance support model is designed to integrate with your operations, quality teams, and management to ensure consistent and sustainable compliance.
Scope of Compliance Support Services
- GMP & GxP Compliance Management
- Ongoing GMP and GxP compliance monitoring
- Schedule M and CDSCO compliance support
- US FDA, WHO-GMP, and EU GMP alignment
- Inspection readiness and audit preparation
- Quality Management System (QMS) Support
- SOP development, review, and implementation
- Deviation, CAPA, and change control management
- Risk management (ICH Q9) implementation
- Management review and quality metrics support
- Regulatory Documentation & Record Compliance
- Batch Manufacturing & Control Records (BMR/BPR)
- Site Master File (SMF) preparation and maintenance
- Quality Manual and Quality Policy development
- Data Integrity (ALCOA+) documentation compliance
- Inspection & Audit Support
- Pre-inspection preparation and mock audits
- On-site and remote support during inspections
- Regulatory observation review and response preparation
- CAPA implementation and follow-up support
- System & Digital Compliance
- Computer System Validation (CSV) support
- ERES and 21 CFR Part 11 compliance
- Data Integrity and electronic record control
- Validation lifecycle and periodic review support
Regulatory Standards & Guidelines Covered
Our compliance support services align with:
- Schedule M & CDSCO Guidelines
- US FDA cGMP Regulations
- WHO-GMP
- EU GMP
- ICH Q7, Q9, Q10
- GxP & Data Integrity Requirements
This ensures readiness for Indian regulatory inspections as well as global audits.
Risk-Based & Practical Compliance Approach
We apply a risk-based compliance strategy focusing on critical processes, high-risk systems, and inspection trends. Our approach helps organizations prevent deviations, reduce audit observations, and maintain compliance in daily operations.
Key Deliverables
- Compliance status reviews and periodic reports
- Actionable compliance improvement plans
- SOPs, formats, and templates aligned to regulations
- CAPA tracking and closure support
- Management dashboards and compliance metrics
Why Choose Our Compliance Support Services?
- Regulatory-Experienced Professionals
Hands-on expertise with CDSCO, FDA, and global inspections. - Continuous Compliance Focus
Not just audit preparation, but long-term compliance sustainability. - Customized Support Models
On-site, remote, or hybrid support tailored to your needs. - Reduced Regulatory Risk
Early identification and control of compliance gaps. - Business-Focused Compliance
Compliance that supports growth, approvals, and supply continuity.
Industries We Support
- Pharmaceutical Formulation Manufacturing
- API & Intermediate Manufacturing
- Medical Device Manufacturers
- Contract Manufacturing Organizations (CMOs)
- Laboratories and Life Sciences Companies
- Start-ups and Expanding Manufacturing Facilities
Stay Compliant. Stay Inspection-Ready.
With increasing regulatory scrutiny and evolving compliance expectations, organizations need reliable compliance support partners. Our Compliance Support services help you stay aligned with regulations, respond confidently to inspections, and build a strong quality culture.
