Validation and
Compliance Testing

Ensuring Your Products Meet the Highest Regulatory and Quality Standards

Comprehensive Validation for Sterile Manufacturing

At Afton Scientific, validation and compliance testing are at the core of our sterile injectable manufacturing services. With decades of experience, we ensure that processes, methods, and equipment consistently meet global regulatory standards, safeguarding product integrity and patient safety.

Our commitment to transparency, reliability, and regulatory excellence ensures that our clients receive precise, compliant, and repeatable validation results.

Cutting-Edge Tools for Rigorous Validation

We leverage advanced technology and best practices to streamline validation processes, including:

Automated Systems for Efficient and Accurate Testing

Reducing variability and improving consistency.

Data Integrity Protocols

Ensuring full traceability and compliance with 21 CFR Part 11.

Expertise in Complex and Specialized Validation Requirements

Managing unique and high-risk processes with precision.

A Seamless Link Between Quality Control and Quality Assurance

At Afton Scientific, quality control is only one part of our comprehensive approach to excellence. Our Quality Assurance team works in tandem with QC to maintain compliance, implement proactive improvements, and oversee regulatory alignment.

 

Learn more about how our Quality Assurance systems enhance reliability, transparency, and industry-leading regulatory compliance adhering to FDA, EMA, PMDA, and ICH guidelines to ensure global compliance.

Why
Choose
Afton?

Proven Expertise in
Aseptic Manufacturing

With 20 years of experience in sterile injectable manufacturing, we bring deep knowledge across biologics and small molecules, ensuring the highest standards of quality and sterility.

Customer-First, High-Touch Service

Afton is built on transparency, flexibility, and trust. We tailor solutions to each project’s needs, offering hands-on support and a commitment to long-term success.

Regulatory Excellence

Our mature Quality Management System (QMS) and strong FDA and international regulatory track record ensure compliance, reliability, and seamless regulatory interactions.

A Strong, Committed Team

With a leadership team in place for over 20 years, we foster a culture of collaboration, integrity, and innovation, ensuring exceptional service and project execution.

Strategic Growth & Investment

Backed by a strategic investment firm, Afton is expanding with new filling lines, isolator systems, and advanced capabilities to meet growing commercial demands.

Partner with Afton Scientific Today

Our team is ready to support your pharmaceutical manufacturing goals.