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Third-Party Audit Services for the Pharmaceutical Industry

In the highly regulated pharmaceutical industry, maintaining compliance and quality is non-negotiable.

At IncepBio, we offer comprehensive third-party audit services designed to evaluate your processes, identify gaps, and ensure your organization aligns with global regulatory standards.

Our team of experienced auditors provides unbiased insights to help you strengthen your quality management system and mitigate risks.

Our Services

1. GMP & GCP Audits

Ensure compliance with Good Manufacturing Practice (GMP) and Good Clinical Practice (GCP) guidelines. We conduct thorough audits of your facilities, processes, and documentation to identify areas for improvement and support readiness for FDA, EMA, and other global regulatory bodies.
2. Supplier Audits

Your supply chain plays a crucial role in product quality. We evaluate your suppliers’ compliance with GMP and other relevant standards, ensuring that your vendors meet your quality expectations and regulatory requirements.
3. Mock Regulatory Inspections

Be prepared for regulatory inspections at any time. Our mock inspections simulate real-world regulatory audits, helping you identify compliance issues and prepare your team for upcoming inspections.
4. Internal Audits

Strengthen your quality management system from within. Our internal audits provide a detailed assessment of your processes, quality controls, and documentation, offering actionable recommendations to enhance your QMS.
5. Data Integrity Audits

Data integrity is crucial for decision-making and regulatory submissions. Our auditors scrutinize your data handling processes to verify the accuracy, consistency, and security of your data management systems.
6. Pre-Certification Audits

Whether you're seeking ISO certification or adhering to other international standards, we conduct pre-certification audits to evaluate your readiness and identify any gaps that could hinder certification success.

Why Choose Us?

Independent Perspective:

As a third-party auditing firm, we offer unbiased assessments that can help you uncover blind spots and achieve lasting improvements.
Industry Expertise:

Our auditors have extensive experience in the pharmaceutical sector, understanding the unique challenges and compliance requirements you face.
Comprehensive Approach:

We provide end-to-end audit services, from planning to follow-up actions, ensuring a complete and thorough evaluation.
Actionable Recommendations:

Our audit reports include clear, practical recommendations to help you address non-conformances and enhance your quality management practices.

Contact Us

Looking to enhance compliance and quality with an independent audit? Contact IncepBio today for a consultation and discover how our third-party audit services can help you meet the highest industry standards.

Why choose us

As a company providing pharma consulting services, we have a wealth of experience in the industry and a team of experts who are knowledgeable about the latest regulations and technologies. Here are some reasons to choose us for your pharma consulting needs: