27
Jun

CONTRACT PHARMA ARTICLE: ICH – Q14 Regulatory Report

CONTRACT PHARMA ARTICLE: ICH – Q14 Regulatory Report: Analytical Procedure Development Paul Mason, Ph.D., Senior Director at Lachman Consultant Services, Inc., offers analysis and commentary on the draft of the new ICH Quality Guideline, ICH Q14, Analytical Procedure Development, and revision of ICH Q2(R2), Guideline on Validation of Analytical Procedures. In this informative article, Paul […]

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14
Jun

Fran Zipp to Present at Medicines for Europe

On Thursday, June 30th, at the Annual Conference of Medicines for Europe, Frances Zipp, President and CEO of Lachman Consultant Services, Inc., will be addressing the audience as a part of the Keynote Speech at the Dolce Sitges Hotel in Barcelona, Spain.  Fran will be addressing humanitarian efforts by industry to provide patients in war-torn […]

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13
Dec

Confused About the Global Requirements for Nitrosamines?

Confused About the Global Requirements for Nitrosamines? We will Help You Navigate This Unchartered Territory! Nitrosamines are a well characterized family of carcinogens that has been identified in thousands of consumer products recently, including small molecule pharmaceuticals and other finished goods. They are produced by the chemical reactions of a nitrosating agent with structural elements […]

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16
Nov

AAM All Access Podcast Special Featuring Bob Pollock Now Available!

Last week, Lachman hosted a virtual booth at the GRx+Biosims 2021 interactive event, where we engaged in a series of dynamic discussions around issues, trends, and challenges vital to the generic and biosimilar medicines industry. The three-day event also featured a podcast special with AAM CEO Dan Leonard and Lachman Senior Advisor Bob Pollock. The […]

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11
Nov

Data Integrity Webinar – Manufacturing & Quality – A Lachman Learning Experience

Data integrity is an ever-increasing concern in life sciences evidenced by the recent activities of the FDA placing its watchful eye on the evolving medical device industry, for the purpose of ensuring safety, and enhancing quality among all manufacturers. Coming under recent scrutiny in the area is data integrity and its far-reaching impact on manufacturing […]

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04
Oct
Video – How to bring a Pharmaceutical, Medical Device or Combination Product to Market!

BRINGING A PHARMACEUTICAL, MEDICAL DEVICE OR COMBINATION PRODUCT TO MARKET?

Then this video is for you. In just five minutes, you’ll discover how the passion for what we do translates into the successful delivery of specialized expertise and services that help you overcome the challenges of an ever-evolving compliance and regulatory environment. The video outlines how you’ll find passion in everything we do, and how […]

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06
May
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Lachman Medical DevicExchange Free Virtual Event Will Be a Gathering of Industry Experts and Executives

As the pandemic approaches its latter stages, it has been more than a year since medical device industry leaders and executives have been able to get together in person at conferences and gatherings to share information and experiences. Opportunities to have virtual events of the same nature have been rare as well. One of those […]

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30
Apr
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Important ISPE Meeting on Quality Risk Management Sustainability

On June 17-18, 2021, ISPE will be hosting a virtual conference, the 2021 ISPE Asia Pacific Pharmaceutical Manufacturing Conference: Sustainable Implementation of Quality Risk Management.  Join leaders from industry (including Lachman’s CEO and President, Fran Zipp) and representatives from international regulators to discuss many issues related to quality risk management, with special emphasis on practical […]

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17
Mar
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Lachman Consultants, Inc. Names John McShane, M.B.A., as VP of Cell & Gene Therapy, Compliance and Business Development

(Westbury, NY – March 16, 2021) Fran Zipp, President and CEO of Lachman Consultants, Inc., a leading provider of compliance, regulatory affairs, and technical services to global life sciences organizations, today announced that John McShane has joined the firm as Vice President of Cell & Gene Therapy, Compliance and Business Development. In this role, McShane […]

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