Our global compliance services ensure your operations meet the highest international standards. We specialize in audits that align with:
Enhance your audit process with our Six Systems Approach, which covers all critical areas of your operations.
Leverage our GMP-certified auditor’s expertise to enhance your quality assurance practices. Our auditor brings:
Qualification from leading global organizations such as Rhone Poulenc (France), Schering Plough (USA), TEVA (Israel), and ADAMAS Consulting (UK).
Conducting audits across API, Excipients, Drug Products, and other domains.
Our GCP expertise is pivotal in ensuring the integrity and quality of your clinical trials. We offer:
Completed 120 BA/BE study audits in Indian CROs.
ISO 9001:2008 (Quality Management), ISO 27001:2005 (Information Security), and Six Sigma Black Belt certified.
Clinical study audits comply with USFDA and EU regulations.
Specialized in GxP-Quality Assurance and Clinical Operations, working with clients from the USA, Belgium, Finland, Italy, and Switzerland.
Offer training in Drug Development, GCP, GCLP, QMS, and consulted for clinical site development and fraud investigations for 16 USFDA studies.
Audited clinical trials in Oncology, Diabetes, Cardiovascular, Respiratory, Orthopedics, Ophthalmic, and Nutraceuticals.
Our IT audit services are designed to strengthen your IT systems and processes. We provide detailed evaluations of:
Reviewing IT documentation and Standard Operating Procedures.
Assessing maintenance practices and Computerized System Validation (CSV).
Schedule a consultation with us to discuss your quality and compliance needs. We’re here to answer your questions and explore how we can support your organization.
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