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Avomeen’s Pharmaceutical Development

Feb 6 2019

Our 25,000 square foot laboratory includes 4 (ISO-7 Compliant) Clean Rooms and Dedicated Formulation Suites to serve our clients’ product development needs. We provide CTM service for Phase I-IIa and partner with you from initial development to final registration. Our expert pharmaceutical scientists have over 30 years of experience providing solid and semi-solid dosage forms…


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How Alkalinity Affects Household Cleaners

Feb 6 2019

We use household cleaners, including multi-surface and glass cleaners, to mop up such a huge variety of messes that the ingredients in each bottle have to be capable of breaking down all kinds of materials. But those ingredients also have to be limited in their capacity to cause damage to humans. Therefore, developing an effective…


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Determining Acceptable Residue Limits in Cleaning Validation

Feb 6 2019

An acceptable residue limit (ARL) is the upper level of residues allowed to remain on a product wherein consumer safety and subsequent product contamination remain controlled. It is part of the standards of cleaning validation undertaken in the pharmaceutical and biopharmaceutical industries. Setting acceptable residue limits ensures that consumers remain unaffected by residues and that…


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How to Make Sure My Company’s Medical Device Meets FDA Standards

Feb 6 2019

Getting your company’s medical device ready to bring to market means working to meet FDA standards. The FDA’s regulations help ensure your medical device is safe for the public, and there are various pathways toward achieving approval. The average timeline for medical device development is roughly 3-7 years, though actual production time can vary significantly…


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Why Pharma Companies Must Invest in Method Development & Validation

Feb 6 2019

Method development is a key element of pharmaceutical development, and it can’t be overlooked when starting the process of creating a new drug. While it’s often considered routine, it’s integral to maintaining cost efficiency. With the right method development and validation guidelines in place, your company can optimize resources and save on development time. Optimize…


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Medical Device Safety The Importance of Extractables & Leachables Testing

Feb 6 2019

Medical devices, whether they’re as simple as disposable examination gloves or as complex as pacemakers, must be proven to be biocompatible before they can go to market. Biocompatibility testing is especially important for devices that are designed to deliver a drug or come into contact with human tissue. Healthcare professionals need to know that no…


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Why Should You Outsource Your Stability Testing?

Feb 6 2019

Stability testing is an essential part of clinical trials, whether you plan to market your product in the U.S. or abroad. Unfortunately, because stability testing involves studying how a product changes over a long period, it’s inherently time-consuming and can monopolize valuable in-house resources. For many manufacturers, the logical solution is to outsource this process.…


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What’s Contaminating Your Pharmaceutical Products?

Feb 6 2019

You believe your pharmaceutical facility is taking every precaution to prevent contamination, but then you discover that there are unidentified spots on a batch of tablets or particles floating in a liquid medication. What’s going on? That question may be difficult or even impossible to answer just from looking at your pharmaceutical product. There are…


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Impurities Testing in Pharmaceutical Products

Feb 6 2019

  Impurities testing for pharmaceuticals is a necessary step in creating a quality product for the market. If your company’s drug is produced with raw materials and APIs from a third-party company, an impurity testing laboratory can verify that ingredients meet quality standards and are in the correct measurements. Do not leave any part of…


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When Does Your Colloidal Oatmeal Product Fall Under FDA Regulations?

Feb 6 2019

In 2003, the FDA-approved colloidal oatmeal as a “skin protectant,” meaning the FDA considers colloidal oatmeal to be an effective ingredient for alleviating dryness, itching, and discomfort caused by certain skin conditions. Since colloidal oatmeal formulations are effective in treating conditions like eczema, psoriasis, and dermatitis, colloidal oatmeal can be found in a wide range…


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