Efficient Batch Review is key to a successful commercial strategy.
BatchWize is focused on the review and release of products regulated by the US FDA. Our process reduces the GMP manufacturing review cycle, identifies potential nonconformances sooner, reduces the manufacturer’s liability, and improves process understanding. We’re here to get your products to market faster and keep them there!
We are reimagining the way products are reviewed and released.
Our team has over 20 years of experience in life science, wellness, nutritionals, quality and regulatory compliance. Our experience includes commercial GMP lot release, clinical lot release, product launch, commercialization of FDA regulated products, and current Good Manufacturing Practices (cGMP) Training.
We focus on product visualization, batch record review, and lot release for GMP manufacturing processes regulated by the U.S. FDA. Products include medical devices, drugs, biologics, combination products, food, supplements, cosmetics, and wellness.
We believe all companies should have access to affordable and reliable Batch Record Reviewers to ensure that valuable, high-quality products get to market quickly and safely.
Read about our company’s commitment to providing vital Batch Review services.
A letter from our CEO
Company Values
Reliable
With over 20 years of experience in the industry, we’ve got your back.
Well Trained
Every team member is a Certified Quality Specialist with ongoing training.
Reproducible
The BatchWize certification program & standardized review processes allow us to hit our target every time.
Responsive
We pride ourselves on excellent customer service & communication skills.
Expedient
Our services are fast and efficient; giving you the outputs you need.
Client Focused
It’s all about your products. BatchWize is here to reduce your liability, costs, & time to market.
Who we are
Meet the Pioneers of BatchWize
We make GMP Batch Release easy
Rebecca Waterbury, ChE, JD
CEO | Co-Founder
Rebecca has over twenty years of experience working with medical device and pharmaceutical life science companies including: Abbott Laboratories, Eli Lilly, Genentech, Biogen, Boston Scientific, Bayer, Philips. She was the founder and CEO of Exemplar Compliance, a full service consulting firm, which she successfully sold in 2020. Her background in operations, quality, and compliance have enabled her to launch regulated products in the US and overseas. Most recently, Rebecca was the VP of PMO and Commercial Launch for Alio, Inc.; a wearable medical device regulated by the FDA.
In her free time Rebecca enjoys camping in the Texas hill country with her family and cooking with friends.
Suthi Nagar, F.H.
COO | Co-Founder
Suthi has worked with supplements and herbal products for over eight years. She has a master’s degree in clinical herbal medicine, and was formerly a clinical practitioner. Prior to joining BatchWize Suthi worked with People’s Pharmacy; a large compound pharmacy and supplement dispensary. Suthi has worked in operations at several companies where she focused on operational planning, staffing, and accounting. Suthi works cross-functionally to implement short and long term goals set by the organization. Her strengths include operational improvements and creating organizational efficiencies.
In her free time Suthi enjoys spending time with her family and can be found paddle boarding in the Austin area!
Advisory Board
We have an incredible advisory team that oversees our programs, assists with technical challenges, and encourages us to build a better organization. Our advisors also keep us updated on industry trends, emerging regulatory topics, and new software.
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Kimberly Snyder
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Angela Frederickson
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Moj Eram
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Ryan Shillington
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Joy Langley