Join Lachman Consultants (Ireland) at the PDA Ireland Event: Contract Manufacturing – Achieving & Maintaining a Successful Partnership, Cork, 29th Feb.

The one-day event will explore how to achieve and maintain good relationships with your Contract Manufacturer Organisation (CMO) Partners. Key industry leaders will share their perspectives on many topics such as the selection of a service provider, regulatory trends, and how to foster collaborative synergies when outsourcing. Lachman Consultants (Ireland) provides a full range of […]

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Our Recent Contract Pharma Article: Nitrosamines Progress from GRx+Biosims 2023 Conference

In case you didn’t have the opportunity to attend the GRx+Biosims 2023 conference or were there and want to revisit the featured panel on nitrosamine impurities, here’s a quick recap and a link to the full Contract Pharma article, authored by Jennifer Leaming, Principal Consultant, Lachman Consultants. Four presentations were made by FDA representatives on […]

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Signs of Progress on the Nitrosamine Front – Notes from the Nitrosamines Session at GRx+Biosims 2023 

The session on nitrosamine impurities was held during the final breakout session on Wednesday morning during the final day of the conference. This session had the largest panel by far of those assembled on any topic presented at the conference, with 15 total panelists including the session moderator!  It was even more difficult than usual […]

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New Guidance for Industry- Acceptable Intake Limits for NDSRIs and a New Webpage from FDA

Unless you’ve been living under a (pharmaceutical) rock, you are aware of the struggle that both FDA and industry are having with Nitrosamines impurities in pharmaceutical products.  As a reminder, APIs are at risk of forming nitrosamine drug substance-related impurities (NDSRIs) when they contain secondary amines or dimethyl tertiary amines. We have published many blogs […]

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FDLI Session Addresses the Nitrosamine Issue

Hundreds of FDA staff, industry professionals, lawyers, and others gathered in Washington, D.C. on May 17th and 18th to participate in the 2023 Food and Drug Law Institute (FDLI) Annual Conference.  The agenda covered a broad range of current regulatory and legal issues facing the food, drug, medical device, biologics, and tobacco industries.  Lachman Consultant Services […]

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Discontinued Chantix – FDA Says Not for S&E Reasons

When a reference listed drug (RLD) product is discontinued from marketing, or if the RLD’s NDA application is officially withdrawn, we all know that the FDA must make a determination that the specific RLD was not discontinued from marketing or withdrawn for safety or efficacy reasons before it can approve an ANDA based on the […]

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Nitrosamines – Where Are We Now?

Two years after the FDA guidance on Control of Nitrosamines Impurities in Human Drugs and nearly a year after the publication of USP’s General Chapter <1469> Nitrosamine Impurities, where are we now and what have we learned?  That was a question posed recently at the Association of Accessible Medicine’s GRx+Biosims 2022 conference.  The session devoted […]

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