We’re scientists, researchers, engineers, and prolific writers. We know the business and we hit the ground running.
A team of our very best writers tackle assignments together to bring decades of experience to your project. Not only do we understand the technical content, but we know what questions to ask and how to find answers.
agencies expect perfection and perfection is what we do best.
Our CER production process allows us to generate high-quality CER documents with impressive speed and accuracy. Our teams work in parallel so tasks are finished simultaneously.
Our CMC team is full of scientists and engineers who can write. Each CMC writer has over ten years of biotechnology process development, manufacturing, quality, and/or pilot plant experience. We understand how to document a process and tie together Critical Quality Attributes and Critical Process Parameters into a comprehensive control strategy that can be validated.
GMWT was founded in 2013 by Emily Stephens and has steadily grown into a 20+ person company. Using a team approach, we provide consistent long term availability and flexibility to respond quickly to your projects. We are trained manufacturing engineers and lab scientists who have spent cumulative decades preparing these documents. We don’t simply write material, we understand it on a fundamental level that enables us to be a go-to source and an information liaison within your company.