All manufacturers of Pharmaceutical, Biologics. Active Ingredients, and Cosmetic Products are required to implement and maintain their compliance with GMP requirements, to assure and demonstrated that their products are consistently produced to quality standards that are appropriate for their intended use.

RAAJ Quality Auditors have the skills and expertise to support companies assess, become and maintain their compliance with cGMP requirements as required by health authorities.

• Audits & Pre-Approval Inspection as per country-specific requirements.
• Regulatory Compliance Audits, and Mock Audits (PAI).
• Conducting Audits as per ISO 13485:2016 and Audits as per ISO 9001:2015
• Investigator site audits
• Quality event management/CAPA
• Vendor audits
• System and process audits
• GLP audits
• GMP audits such as FDA, PMDA Japan, Health Canada. NMPA China or ANVISA (Brazil inspections) according to 21 CFR 210.
• Regulatory inspection preparation support and management
• Regulatory GxP training
• Oversight and management of document control.