GMP Support Services, Pharma Consulting & Training and Third-Party Audit
We provides comprehensive GMP support, pharmaceutical consulting, professional training, and third-party audit services to help pharmaceutical, biotechnology, medical device, and life sciences organizations achieve and maintain regulatory compliance.
Our experienced consultants work closely with your team to strengthen quality systems, improve operational efficiency, ensure inspection readiness, and build internal technical capabilities through practical consulting and industry-focused training.
Standard We Follow:
- EU GMP
- FDA cGMP
- WHO GMP
- PIC/S GMP
- ICH Guidelines
- GAMP® 5
- ALCOA+
- 21 CFR Part 11
- EU Annex 11
- ISO 9001:2015
- ISO 14644
GMP Support Services
- 1. GMP Compliance Support
- 2. Documentation Review
- 3. SOP Development & Review
- 4. Quality Management System (QMS) Support
- 5. QC Compliance and QC data Upload
- 6. Data Integrity Assessment
- 7. Audit Trail Review
- 8. LIMS Implementation and Master Data Creation
- 9. IT Infrastructure Support
- 10. Application Support
- 11. Vendor Management and Qualification
- 12. Regulatory Inspection Readiness
- 13. eBMR, eBPR, ERP, and other software data Upload
Pharma Consulting
- 1. GMP Consulting
- 2. Validation Consulting
- 3. Facility & Utility Consulting
- 4. CSV & Digital Compliance Consulting
- 5. Commissioning, Qualification & Validation Consulting
- 6. Process Improvement
- 7. Regulatory Compliance Consulting
- 8. Remediation Projects
- 9. Greenfield Project Support
Training Programs
- 1. GMP Training
- 2. GDP Training
- 3. Data Integrity Training
- 4. CSV & CSA Training
- 5. GAMP® 5 Training
- 6. CQV Training
- 7. HVAC Validation Training
- 8. Cleanroom Behaviour Training
- 9. Thermal Validation Training
- 10. ALCOA+ Principles
- 11. Regulatory Inspection Readiness
Third-Party Audit Services
- 1. GMP Compliance Audits
- 2. Internal Audits
- 3. Supplier Audits
- 4. Vendor Qualification Audits
- 5. Facility Audits
- 6. Quality System Audits
- 7. Data Integrity Audits
- 8. Mock Regulatory Audits
- 9. Gap Assessment Audits
- 10. Audit Observation Closure Support
Key Deliverables
Depending on project scope, we provide:
- 1. Gap Assessment Report
- 2. Audit Report
- 3. Risk Assessment
- 4. SOPs
- 5. Policies
- 6. CAPA Plan
- 7. Training Material
- 8. Attendance Records
- 9. Competency Assessment
- 10. Validation Documentation
- 11. Compliance Roadmap
- 12. Executive Summary Report
Why Choose Cleanstep?
- 1. Experienced GMP Consultants
- 2. Regulatory-Focused Solutions
- 3. Industry-Oriented Training Programs
- 4. Independent Third-Party Audits
- 5. Practical & Business-Focused Consulting
- 6. End-to-End Compliance Partnership
Need GMP Consulting, Training, or Third-Party Audit Support?
Partner with Cleanstep Pharma and Engineering Solutions for practical, regulatory-compliant consulting, professional training, and independent audit services. We help organizations strengthen quality systems, achieve compliance, and maintain inspection readiness through expert guidance and tailored solutions.
