BatchWize is Batch Review and Lot Release made easy.
Batch Review
& Lot Release made easy.
We get your products to market faster and keep them there.
BatchWize™ is a highly trained team that specializes in Manufacturing Batch Record Review and Lot Release for FDA regulated products. We partner with life science, medical device, pharmaceutical, biologic, food, cosmetic, and health & wellness companies to save our clients time and money.
Our Team
Certified Specialists focus on Batch Record Review and Lot Release, allowing our clients the ability to allocate their resources to other projects.
Our Promise
Large or small, Batch Review is an essential part of your production process and BatchWize is your one stop solution for product release.
Our Method
We reduce the time and expense associated with batch release while helping our clients maintain market access.
How we work
We believe in building strong relationships and earning trust from the very first engagement.
Let our team of experts save you time and money by providing a thorough Batch Record Review with recommended corrective actions and final disposition.
Our Process + What to Expect
Initial Call - To confirm customer needs and regulatory requirements
Data Review - Structured data review using our in-house process
Report & Discuss - Initial findings
Release - Recommended disposition with final report
Batch Record Review ensures the manufacturer or license holder is distributing compliant products to the market that meet all product specifications and quality requirements.
Why you need experienced Batch Review
Batch Record Review can keep adulterated products from being released into the stream of commerce, and ensure that only “Quality” products representative of your brand are made commercial.
Batch Release a headache? Here’s how BatchWize makes it easy.
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BatchWize creates a focused review with detailed findings, saving multiple iterations of Manufacturing / CMO / Quality Units and reducing the overall manufacturing costs.
Products are released faster, enabling our clients to gain market share, ensuring order fulfillment, and enabling repeat sales; preventing spoilage, expired and short-dated products on shelves.
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The BatchWize review looks at the entirety of the batch record in context. We evaluated manufacturing records, specifications, nonconformances, testing, FDA requirements, and certifications to ensure a complete story is told within the documentation; making it easier for future auditors and investigators to review the files.
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A backlog of aging records can cause serious quality issues and product delays.
BatchWize provides efficient & focused review of backlogged records and can supplement existing staff with batch record and nonconformance review.
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External consulting groups can be very expensive; many charge $300-$450 per hour.
BatchWize specializes in activities surrounding batch review and lot release. We take a focused approach to Batch Review to save our clients time and money.
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BatchWize reduces your liability, with a thorough review, ensuring adequate documentation and reducing regulatory risk (US FDA).
Our review process supports continued market access, reducing the possibility of a public recall.
Schedule a free initial consultation with us!
BatchWize gets products released to market faster and keeps them there!
Tell us more about your products and regulatory needs. Our Batch Record Review & Lot Release process can adapt to your unique company requirements.
Click the link below to book your call!
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