Regulatory and Compliance

Maintaining Compliance

Medical device, pharmaceutical and biotechnology/biopharmaceutical companies are regulated by the FDA and other global regulatory bodies.  Regulations aim to ensure that products are deemed relatively safe and effective throughout their total product life cycle.  Each phase of product pipeline requires appropriate planning, implementation and testing to ensure regulatory compliance, remove risk from the development process and get products to market in a timely manner.

Maintaining Compliance

Why

Regulations are complicated and requirements may change.  Navigating product development – from R&D to CQV – will make the difference in financial performance and speed to market.

How

Apex helps clients implement or remediate processes, systems or key components of their Quality Management System (QMS) while focusing on industry alignment, quality, and productivity.

Value

Implement sustainable, maintainable and compliant solutions, develop fully validated production processes and ensure adherence to the requisite FDA regulations, International standards and company requirements.

/insights/fmea-and-computer-system-validation
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Woman in lab coat working on computer
FMEA and Computer System Validation
Identified gaps in procedures and controls and implemented mitigation actions.  
Case StudyLife Sciences
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Man with hardhat looking at ipad
CQV for New Automated Manufacturing Equipment
Replacing legacy manufacturing equipment to keep up with industry requirements.  
Case StudyLife Sciences
/insights/cqv-new-blister-and-bottle-filling-lines
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white bottles
CQV for New Blister and Bottle Filling Lines
Facility expansion to minimize project costs under a tight timeline. 
Case StudyLife Sciences
What our clients say
"Outstanding performance, flexibility and willingness to go the extra mile to meet all requirements."
Global Initiatives Program Director

Leadership

Lynn Bierling
Director, Regulatory and Compliance

Senior Vice President with over 20 years of staffing expertise and laboratory experience. Currently, lead and manage a consulting team servicing clients in the Life Science Industry. Prior experience includes Quality, Manufacturing, and Research Laboratory experiences in the Biotech, Pharmaceutical, and Food industries.