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- Hyderabad, INDIA
- Office Time:
- Monday to Friday 9:00am - 6:00pm
- Call Us:
- +91 76006 48002
- Email:
- info@qualyinc.com
Services
Our Services
GMP Gap Analysis
At QualyInc, our GMP Gap Analysis service is designed to identify areas of non-compliance within your operations, ensuring your organization is fully aligned with global Good Manufacturing Practices (GMP) standards. We take a systematic approach to evaluate your processes, systems, and documentation against regulatory requirements, industry best practices, and your specific operational goals.
Audit Readiness Preparation
At QualyInc, we understand the critical importance of being prepared for regulatory inspections and audits. Our Audit Readiness Preparation service equips your organization with the tools, strategies, and confidence needed to excel during audits by regulatory authorities, clients, or internal teams.
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Audit Response and Remediation
At QualyInc, we specialize in guiding organizations through the critical phases of audit response and remediation. Whether you’re addressing observations from regulatory inspections, client audits, or internal reviews, our team provides the expertise needed to navigate these challenges effectively.
Regulatory Compliance Strategy
Navigating th e complex landscape of global regulatory requirements demands a strategic approach. At QualyInc, our Regulatory Compliance Strategy service helps organizations proactively align their operations with evolving standards in the pharmaceutical, biologics, medical device, and diagnostics industries.
Quality System Development and Strengthening
A robust quality system is the backbone of compliance and operational excellence. At QualyInc, we specialize in developing and strengthening quality management systems (QMS) tailored to the unique needs of the pharmaceutical, biologics, medical device, and diagnostics industries.
Process Validation & Documentation Support
Ensuring consistent product quality and compliance requires meticulous process validation and precise documentation. At QualyInc, we offer expert support to help organizations establish and maintain robust validation protocols that meet global regulatory expectations.
Staff Training & Inspection Readiness
A well-trained team is crucial for maintaining compliance and excelling during inspections. At QualyInc, our Staff Training and Inspection Readiness services are designed to empower your workforce with the knowledge and skills needed to navigate regulatory expectations confidently.
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