Consulting – Goods Manufacturing Practices (GMP) Consulting Services

General Quality Assurance and GMP compliance concerns
Reviewing Supplier Agreements
Laboratory Data Processing Services
Design, Implementation of Quality Systems, Vendor Qualification, Inspections, and Mock Pre-approval Audits.

 

Auditing – Audits are an effective means of evaluating compliance with the objectives of the quality system and providing feedback to management as part of a continuous improvement program. Our services include GCP audits, GLP audits, bioanalytical laboratory audits, central laboratory audits, CRO audits, vendor audits, sponsor audits, CSV audits, cGMP audits.

 

We provide mock audits to get you ready and perform maturity assessments of IT systems.

• cGMP Audits and Assessment as per USFDA/EU/MHRA/Geneva WHO
• Third-Party IT Vendor Audits
• Regulatory Assessments (21 CFR Part 11…)
• GAMP5 Assessments
• IT Maturity Assessment
• Virtual Vendor Audits

 

Quality Standards and Guidelines: We provide audits for below standards

• US FDA 21 CFR Part 11
• GAMP 5
• EU Annex 11
• 21 CFR 820
• ISO 13485
• ISO 9001:2015

 

Regulatory Bodies:

• US FDA 
• MHRA
• MCA 
• TGA