04
Aug

Responding to Consumer Complaints While Working with CMOs

Ricki Chase, M.S., Vice President, Lachman Consultant Services, Inc. (Lachman Consultants) and Carrie Colella, Senior Director, Lachman Consultant Services, Inc. (Lachman Consultants) take an in-depth look at the questions and challenges manufacturers face and how to respond to consumer product complaints while working with a contract manufacturing organization (CMO). The product, in this case, may […]

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11
Jul

Lachman Consultant Services, Inc. Names Marty Shimer as Executive Director, Regulatory

(Westbury, NY – July 11, 2022) – Frances Zipp, President and CEO of Lachman Consultant Services, Inc. (Lachman Consultants), a leading provider of compliance, regulatory affairs, and technical services to global life sciences organizations, announced today that CAPT Martin H. Shimer, II joined the firm as Executive Director, Regulatory, effective July 11, 2022. In this […]

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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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24
Feb

QSR – ISO Harmonization – All Things Being Equal…They Are Not – A Deeper Dive

The US Food and Drug Administration published their much-anticipated proposed rule (PR) to amend the Quality System Regulation (QSR) (21 CFR Part 820) on February 23, 2022.  After four years in the works and much debate about what the PR would include, we can finally read it for ourselves.  The question in my mind was […]

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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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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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