Quality
Built into
every step
Integrated quality systems supporting biologics development and manufacturing from early development through commercial supply.
NUMBERS
A Track Record You Can Trust
Proven through inspections and approvals
Years of successful inspection history​
Successful pre-license inspections supporting client BLA approvals
Years of continuous FDA-inspected biologics manufacturing experience
VALUE
Quality is the Foundation
In biologics, the process defines the product and quality defines the process.
At Avid, quality is not a separate function. It is built into how work is performed across development, manufacturing, analytical testing, and regulatory documentation.
This integrated approach supports consistent execution, reliable data, and readiness for regulatory review at every stage of your program.
quality
One Commitment.
Multiple Advantages.
How quality supports your program
Quality as differentiation: A consistent inspection record reflects the maturity and reliability of Avid’s quality systems.
Quality as program support: Strong quality systems enable consistent manufacturing, clear documentation, and efficient regulatory review.
Quality as continuous readiness: Processes and documentation are maintained in a state of ongoing inspection readiness.
QUALITY
Quality is Integrated
Across Every Function
CGMP Quality Management System
ICH Q10-aligned systems governing development, manufacturing, and analytical operations.
FDA Inspection Track Record
A documented history of successful inspections and regulatory outcomes.
Quality Agreements
Clearly defined responsibilities and communication protocols aligned with regulatory expectations.
Deviation & CAPA Management
Structured investigation and continuous improvement processes.
Batch Release & Lot Disposition
Formal review and release of all clinical and commercial lots under quality oversight.
Stability Program Management
ICH-compliant stability studies supporting IND, BLA, and lifecycle management.
REGULATORY
Built for Regulatory Confidence
Aligned with FDA and global expectations
Avid’s quality systems are designed to support regulatory submissions and inspections across the full lifecycle from IND through BLA and commercial manufacturing.
Documentation, controls, and processes are structured to meet FDA and international regulatory expectations at every stage.
Experience
Pre-License &
Pre-Approval Inspections
Experience where it matters most
The pre-license inspection (PLI)/pre-approval inspection (PAI) is a critical milestone in the path to approval.
Avid has successfully supported 10 PLIs, including recent approvals, with a consistent approach built on preparation, alignment, and execution.
This experience reflects a quality system maintained in a state of readiness ensuring programs are well-positioned for regulatory review.
QUALITY
Quality Across the Program Lifecycle
From Early Development to Commercial Supply
Early Development: Quality frameworks supporting IND-enabling work and documentation.
Clinical Manufacturing: CGMP systems supporting clinical supply and regulatory submissions.
Commercial Manufacturing: Validated processes, ongoing monitoring, and inspection-ready operations.
One Standard. Every Team.
Quality at Avid is shared across every function from scientists and engineers to quality and regulatory teams.
This alignment ensures that quality considerations are part of every decision, supporting consistent performance and reliable outcomes across your program.
Why Us
Why Avid Bioservices
Integrated Quality Systems
Quality embedded across development, manufacturing, and analytical functions.
Proven Inspection Performance
Consistent outcomes across FDA inspections and regulatory reviews.
Regulatory Alignment
Systems designed to support IND, BLA, and commercial manufacturing.
End-to-End Continuity
The same quality system across all program stages.
U.S.-Based Operations
Domestic facilities with long-standing FDA experience.
30+ Years of Demonstrated Performance
A track record that supports long-term program success.
Build your program
on a strong foundation
Connect with our quality team to learn how Avid supports consistent, inspection-ready
biologics manufacturing.
Learn More
Quality FAQs
A pre-license inspection is an FDA evaluation of a manufacturing facility and process conducted before approval of a biologics license application (BLA), confirming readiness for commercial production.
An FDA 483 documents inspection observations related to CGMP compliance. Strong quality systems help ensure consistent inspection outcomes.
A quality agreement defines responsibilities, communication protocols, and compliance expectations between a sponsor and a CDMO.
Corrective and preventive action (CAPA) systems identify root causes of issues and implement improvements to ensure consistent quality.
Inspection history reflects the maturity and reliability of a CDMO’s quality systems and its ability to support regulatory success.
Quality systems ensure data integrity, documentation accuracy, and process control supporting IND, BLA, and commercial approvals.