Alleviate Audit Challenges

Agency Audit Response

When you are responding to an agency audit findings, it seems like there are not enough resources to get it all done. Our consultants have the expertise and experience to help you every step of the way.

We can take the burden off your team and get to work on your CAPAS, ensuring that you meet your audit response deadlines and deliver high quality reporting to regulatory authorities.

Audit Readiness

Compliance under adverse audit findings can be stressful and can cost your company precious time and money. We can proactively conduct CGMP audits, identify improvement opportunities, and working closely with senior leadership, implement corrective measures so you are better prepared.

Supplier Audits

In a business environment where global supply chains are under stress, qualifying alternates and maintaining existing suppliers are essential for business success. Whether you need help with improving supplier capability, or to resolve supplier quality issues, we can help by partnering with your supplier to identify and implement corrective measures. We also conduct onsite audits as part of our effort to help you qualify new suppliers.

CDMO Audits

CDMOs are used widely in the BioPharma industry for both clinical and commercial operations. We can conduct phase appropriate CGMP audits and assess capability of potential contract manufacturers (CDMOs) you are considering and lay the groundwork for tech transfer efforts.

We can also help manage the ongoing compliance responsibility with CDMOs thorough audits and verification of manufacturing processes and quality management systems

Agency Audit Programs

Develop remediation plans for agency audit findings and Implement CAPAS
Conduct cGMP audits and recommend improvements
Audit preparation and readiness
Policies and Procedures

Supplier Audit Programs

Raw Material supplier audits
Single Use Component supplier audits
Sterilization Vendor audits
Equipment vendor selection audits, FAT

CDMO Audit Programs

Contract manufacturer (CDMO) qualification audits
Process Fit assessments for Tech transfers

Audit Video 11-09-2022.mp4

Whether you are preparing for an audit, or responding to an agency audit finding, it seems like there are not enough resources to get it all done. Our consultants have the expertise and experience to help you every step of the way.

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