Mastering Regulatory Compliance
Expert Audit Services
At Tech Qualitas, we understand the critical importance of audits in ensuring compliance with regulatory standards and industry best practices. Our audit services are designed to provide thorough assessments of various aspects of your operations, helping you identify areas for improvement and mitigate risks effectively.
Masters of Audit Excellence
Unrivaled Expertise
Certified Auditors
Our auditors boast certifications from esteemed global entities such as Rhone Poulenc, TEVA and Schering Plough, ensuring unmatched expertise in every audit engagement.
Extensive Expertise
Specializing in API, Excipients, Drug Products, Formulation R&D, CROs, Contract Testing Laboratories, and Distribution Centers, our team has conducted audits for prominent regulatory bodies worldwide, including USFDA, EU, TGA, WHO, PICS, MHRA, PMDA, MCC, ANVISA, and Health Canada.
Comprehensive Solutions
Beyond conducting audits, we offer tailored audit remediation plans, CAPA proposals, and comprehensive review and evaluation services to streamline compliance with regulatory mandates.
Comprehensive Services Across the Pharmaceutical Spectrum
Harness the strength of Tech Qualitas’ 40 years of industry leadership with our Computerized System Validation (CSV) solutions. We streamline compliance for your systems, ensuring a harmonious blend of efficiency and adherence to industry standards.
- API/Excipients/Drug Products/Formulation R&D Audits: Comprehensive assessments of manufacturing processes, quality control measures, and regulatory compliance.
- CRO Audits: Evaluation of clinical research organizations conducting clinical studies to ensure adherence to protocols and regulatory standards.
- Toll Manufacturing Sites Audits: Thorough assessments of toll manufacturing facilities to verify compliance with quality standards and regulatory requirements.
- Contract Testing Laboratories Audits: Evaluation of contract testing laboratories to ensure the accuracy, reliability, and integrity of analytical and microbiological services.
- Distribution Centers (Warehouses) Audits: Assessments of distribution centers to verify proper storage, handling, and distribution practices for pharmaceutical products.
- IT Related Audits: Our IT-related audit services encompass documentation, SOP effectiveness, system maintenance, backup procedures, CSV, infrastructure validation, and network audits.
- Production and QC System Audits: Our audits extend to production and QC systems, covering CSV, IT policy, data security, and audit trail review.
- CAPA, Change Control, and Deviation Review: CAPA, change control, and deviation review services, verifying their effectiveness and ensuring compliance with regulatory standards
Why Choose Tech Qualitas for Your Audits?
Industry Leading Expertise
Our team brings decades of experience and industry expertise to every audit, ensuring thorough assessments and actionable recommendations for improvement.
Global Reach
With a global presence and a network of experienced auditors, we can support audits for clients worldwide, across various regulatory jurisdictions.
Commitment to Excellence
At Tech Qualitas, we are committed to delivering high-quality audit services that help our clients enhance compliance, mitigate risks, and improve operational efficiency.
Contact Us
Get Expert Solutions Now!
Reach out to Tech Qualitas and explore bespoke technological solutions meticulously crafted to meet your business needs. Our team is ready to assist you on your journey towards operational excellence. Whether you have inquiries, need consultation, or are ready to initiate a collaboration, we’re here to help. Connect with us today and let’s navigate the path to success together.
Company Mail
info@techqualitas.com
Phone Number
+91 9625361687
