Technical Guidance
Our Technical Expertise:
- Quality Management Systems (QMS) Consultancy
- Implementation and support for ISO 9001, ISO 13485, ISO 17025, ISO 14001
- Implementation and support for ISO 9001, ISO 13485, ISO 17025, ISO 14001
- Regulatory Compliance Guidance
- Support for WHO, EU-GMP, US-FDA, MHRA, TGA inspections & audits
- Support for WHO, EU-GMP, US-FDA, MHRA, TGA inspections & audits
- Process Validation Consultancy
- Guidance on validation protocols (IQ/OQ/PQ), thermal studies, sterilization & environmental validation
- Guidance on validation protocols (IQ/OQ/PQ), thermal studies, sterilization & environmental validation
- Pharmaceutical & Medical Device Consultancy
- Support for compliance with CDSCO, CE marking, and global standards
- Support for compliance with CDSCO, CE marking, and global standards
- Training & Documentation Support
- Customized training for QA/QC teams and preparation of SOPs, protocols & audit documentation