Regulatory Compliance

Regulatory Compliance

We usher our clients to comply with various national & international standards such as obtaining a Manufacturing License and also compliance certifications like cGMP, EU-GMP, CEP, PICS, MHRA, TGA, ANVISA & USFDA.

Compliance portfolio

• Site Master File development
• Validation Master Plan design
• Master Formula Record design
• Batch manufacturing & Packaging record design
• Standard operating procedures development
• Equipment & Instrument qualification execution & reporting
• HVAC qualification execution & reporting
• Water System Qualification execution & reporting
• Utilities Qualification execution & reporting
• Validation execution & reporting
• Quality control system execution & reporting
• Training & evaluation documentation
• Ensuring continued compliance
• Pre-inspection audits execution & reporting
• vendor compliance audits execution & reporting
• bridging gap assessment for achievement of compliance