Will my E-Liquid Product Receive PMTA Authorization?

Sep 12 2019

It seems like everyone in the vape industry is asking if their e-liquid and ENDS products will receive Premarket Tobacco Application (PMTA) authorization. While there’s no guarantee as to whether or not FDA will grant authorization for your PMTA, a few common strategies have emerged amongst leading ENDS manufacturers. With the final guidance and due…

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Pharma Formulation Services Blog Series, Part 3: From Lab To Suite – Considerations for Scaling Up

Sep 10 2019

When you finally arrive at a formulation that meets the target product profile, it is then necessary to devise a process by which it can be manufactured at scale. What started as a concept with beakers, stirring rods, and pipettes must become a process with bulk handling and automated or semi-automated equipment. Steps such as…

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Good ANDA Submission Practices

Sep 5 2019

The cost and time spent on filing an ANDA with FDA are demanding. Once all aspects of the file are ready for submission, it would be assuring to know that you’ve done all you can to be granted approval. There are four major areas that FDA cites in Good ANDA Submission Practices-Guidance for Industry which…

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A Timeline for Elemental Impurities Testing

Sep 3 2019

Heavy metal impurities can creep into pharma or biopharma formulations throughout drug development, from initial design to large-scale manufacturing. Their presence can affect the efficacy and safety of your final product and significantly delay its time-to-market. To free up resources and remain on course, it pays to find a responsive research partner with specific expertise…

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Regain Control of Your Formulation with Deformulation

Aug 29 2019

It’s not uncommon to build a brand on a product that was developed in partnership with a contract manufacturer. For a number of entrepreneurs, start-ups, and small businesses in the early stages of building their brand, the cost savings associated with developing a product in conjunction with a contract manufacturer outweigh the risk of the…

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New FDA Regulations are on the Horizon for OTC Sunscreens

Aug 27 2019

FDA published a press release about new proposed regulations which will ensure that non-prescription, over-the-counter (OTC) sunscreen products are not only safe, but effective in late February of 2019. The proposed regulations would impact and update the regulatory requirements for the majority of sunscreen products in the U.S., which are marketed without FDA-approved applications. Regulations…

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The Use of Ion Chromatography for Measuring Residual Ions in Drug Product

Aug 22 2019

Ion Chromatography (IC) is a liquid chromatographic method that’s used to separate and analyze ionic molecules. IC is a preferred method to analyze active pharmaceutical ingredients (APIs), excipients, degradation products, and/or impurities that contain inorganic and organic ions, polar substances, or chemically similar analytes. IC is becoming a more prevalent analytical tool in biopharma, and…

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Strategic Partnership Blog Series, Part 1: Benefits

Aug 20 2019

Why would I want to form a strategic partnership with a 3rd party lab? A long-standing client of mine from early in my career used to talk about two principles of a strong business relationship.  The first (with an obvious nod to Robert De Niro from Meet the Parents) was the “Circle of Trust”.  It’s…

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Key Tests and Equipment for Analytical E-Liquids Testing

Aug 16 2019

Small scale e-liquids manufacturers can sometimes have difficulty understanding the complex instrumentation and methods used for analytical testing. You may be wondering if you need to perform all of the analytical tests that are available or what exactly is required for compliance by different regulatory agencies. To help you understand some of the important methods…

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Pharma Formulation Services Blog Series, Part 2: Respect the Chemistry

Aug 15 2019

Sometimes you have no choice.  “You can have any color you want ‘so long as it is black.’”  “Ice cream sold here: vanilla.”  You get the idea. So it is with formulation.  A substance will demand certain treatment.  An API with the solubility of brick dust requires a dosage form to enhance solubility.  An API…

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