Nikolas Burlew

Vice President, GxP/CMC Quality Assurance

Engage with an experienced partner well-versed in the ever-changing regulatory landscape to help avoid not complying with GMP rules and regulations.

A day in my life at Clinipace

Review new good manufacturing practice warning letters, drug and biologic Guidance documents and federal register notices, answer ad hoc quality assurance questions, and define a formal QA stance on an issue ranging from packaging to API validation.

My “a-ha!” moment

During a “scorched earth” audit we dug deep enough to find multiple batches of six different products that needed to be recalled to protect patients.

The most important consideration a client should take when undertaking a clinical research project

ALL drugs going into humans MUST follow good manufacturing practices. GMP is a sliding scale, meaning that they must be more rigorously applied as products move forward in development. During Phase I, less detailed application of the regulations will be expected.  By the time a product reaches Phase III clinical trials, GMPs are expected to be strictly adhered to during manufacturing.  Engaging an experienced partner well versed in the ever-changing regulatory landscape helps avoid not complying with GMP rules and regulations.

One of the biggest misconceptions I run up against in my daily duties is

Good laboratory practice does not apply to the quality control lab supporting GMP manufacture.

Professional organizations

Parenteral Drug Association (PDA), Mountain States Chapter of the PDA, Society of Quality Assurance (SQA), Rocky Mountain Regional Chapter of the SQA

Clinipace Worldwide
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