Pharmaceutical Labels

ATL has established a well-respected name in the marketplace as the solutions provider in the tough arena of FDA cGMP Compliance. For over a decade we have manufactured multi-panel and multi-lingual pharmaceutical labels for more than 1,800 clinical trials that took place 100+ countries. ATL is audited on a regular basis (by the top pharmaceutical companies) for our quality systems, validation protocols, and traceability of product (batch records). ATL remains committed to the philosophy of "quality first." Our employees follow the strict FDA regulations of 21 CFR 210 and 211.

Every pharmaceutical label (both single ply and multi-panel) to be manufactured in our facility has a systematic review (before production). This includes APQP (Advanced Product Quality Planning) for specifications, materials, tooling, control plans, performance qualifications, and batch inspection records . This "discipline" follows the product from the project engineer, through customer service, quality, and shipping. Our Quality System has "Travelers" and "Hold Points" that assure line clearance, product integrity, and cGMP compliance. Only our Quality Assurance department is authorized to release the product at each "hold" point, and only after conformance to specifications is achieved. This process ensures a confidential, secure and quality product for our customers.

Disposable Medical Devices

As an FDA registered medical device manufacturer and one of fourteen 3M Medical Preferred Converters, we craft precision medical devices shipped worldwide. Our services range from master roll distribution of medical foams and tapes to custom die cut components with tight tolerances. Our experienced engineering team will work closely with you on material selections and prototypes. ATL follows the strict FDA regulations of cGMP compliance to 21 CFR 820 for the manufacturing, packaging, and storage of medical devices.