Quality Assurance

Top quality scientific data is priority one — that’s why we integrate quality it into everything we do.

The best chance at a successful drug submission begins—and ends—with a robust pharmaceutical quality system.

Pharmaceutical quality systems (PQS) are critical to ensuring drugs are manufactured to meet quality and performance standards as mandated by regulatory authorities globally. In fact, pharmaceutical quality is so important that during FDA inspections, the PQS is assessed as a key factor for supporting drug submissions.

At Custom Biologics, we boast a world-class PQS. Our independent Quality Assurance Unit (QAU) implements the latest regulatory guidelines for bioanalytical and biological assay validation, and routine scientific analysis to ensure the quality, traceability and integrity of the data. These high standards are met for work conducted in the course of research and development or for submission to a regulatory agency.

All work at Custom Biologics™ is conducted in strict compliance with Good Laboratory Practice quality principles in a state-of-the-art facility fully compliant with FDA guidelines, 21 CFR Parts 11 and 58.

Our Four Point Quality Control System

Our Site Master File provides a blueprint of our Quality System. The four pillars on which it is built are described.

1. Implementing Quality-Driven Processes

Our rigorous Quality System is managed by a team of QA professionals who ensure all experimental work generated in a quality driven environment is documented and carefully reviewed according to established standard operating procedures.

3. Communication, Transparency & Integrity

We are committed to always being accessible and responsive to our clients.  Detailed study protocols and regularly scheduled project review meetings always ensure close cooperation with our clients.

2. Maintain a Clean & Safe Environment

Controlled access to Custom Biologics is restricted to employees and qualified personnel. Routine environmental monitoring, equipment calibration and preventive maintenance ensure a safe, reliable working environment to generate trustworthy data.

4. Consistent Quality Across All Our Platforms

All experimental platforms and laboratory equipment are properly implemented through regulatory compliant IQ/OQ/PQ procedures and maintained on regular preventative maintenance schedules.

Our Experience

Over 50 years of combined expertise in maintaining and implementing quality systems relating to pre-clinical functional characterization and clinical testing of biotherapeutic drugs and to the development and validation of molecular diagnostic assays.

Scientific, Pre-clinical, Clinical, Diagnostics, Manufacturing & Regulatory Compliance Systems
Quality Management Systems
GLP/GMP Audits
GLP/GMP Training
ISO13485/Health Canada Drug Establishment License
Documentation for regulatory submission
Record Management and Archives
Regulatory Guidance for Assay Design

Stand out and reach your goals faster with our top-tier pharmaceutical quality system

Our quality assurance experts will assist you every step of the way as you navigate and meet regulatory requirements for your drug subsmission.

Contact us today