Former FDA and Regulatory Experts from Lachman Consultants, Inc., to Serve as Panelists at AAM GRx & Biosimilars Meeting

(Westbury, NY— November 2019) Two top FDA and industry experts from Lachman Consultant Services, Inc., (“Lachman Consultants”) will be participating as panelists at The Association for Accessible Medicines (AAM) Generic (GRx) and Biosimilar (Biosims) Conference, also known as AAM GRx+Biosims, on November 4-6, 2019, at the Bethesda North Marriott Hotel & Conference Center in Bethesda,

Lachman Consultants Travels to India for the 5th Annual Data Integrity, Reliability, and Quality Metrics Workshop

Three Key Representatives from Lachman Consultants will be traveling to India on July 30 – August 1 for the 5th Annual Data Integrity, Reliability, and Quality Metrics Workshop. This 3-day interactive training event features experts from Lachman Consultants, Frances Zipp, President & CEO, Linda Evans O'Connor, Head of Business Processes and Regulatory, and Dr. Ron [...]

How To Address Nitrosamines In The Pharmaceutical World

Contract Pharma published an article back in May discussing the issue of Nitrosamines uninvitedly found in drug products. The article’s author, Aloka Srinivasan, VP of Lachman Consultants, helps us better understand the presence of Nitrosamines and how to address them. Nitrosamines has recently re-surfaced in the pharmaceutical world due to FDA and other international agencies finding traces of these compounds in the angiotensin II receptor blockers (ARBs),

Frances Zipp Shares Market Insights at the CPhI China Exhibition in Shanghai

On June 20, 2019, LCS’ President and CEO Fran Zipp, moderated a panel at the CPhI China exhibition in Shanghai, organized by Informa Markets. The panel discussion, “How Can International and Domestic Manufacturers Collaborate to Improve Quality?” included members from a number of different segments of the regulated industry. Members on the panel were: Aurelio Arias,

Back view business woman raising hand for asking speaker for question and answer concept in meeting room for seminar


As always, Lachman Consultants looks to provide excellence in all phases of serving our clients’ needs, so we paid close attention to the various speakers, panels and general goings-on at the 2019 ISPE Europe meeting to take the pulse of the industry.  We also spoke to many of the show’s attendees, and the takeaways from our many observations and conversations covered a variety of topics.  

Lachman Consultants Returns to ISPE Europe 2019

(Westbury, NY – March 2019) On the heels of establishing a European based presence last year, Lachman Consultant Services, Inc., a leading provider of expert compliance, regulatory affairs, and technical services to life sciences organizations worldwide, will return to the ISPE Europe 2019 Annual Conference. Lachman is sponsoring the event on April 1-4,

Lachman Consultants to Offer Insights on Future Transition of Biological Products at the 2019 Parenteral Drug Association (PDA) Annual Meeting

(Westbury, NY – February 2019) Lachman Consultant Services, Inc., a leading provider of expert compliance, regulatory affairs and technical services to life sciences organizations worldwide will be a Bronze Sponsor at the 2019 Annual Meeting of the Parenteral Drug Association (PDA), Booth #308, March 11-13, at the Marriott Marquis San Diego, San Diego, CA. Themed “Solving Manufacturing and Supply Challenges for Current and Future Medicinal Products,” the PDA’s flagship Annual Meeting provides a venue for obtaining the latest information on parenteral processing,

Happy Holidays – FDA Issues Highly Anticipated Revised Quality Metrics Guidance

On Thanksgiving Eve, FDA issued the revised Quality Metrics Guidance. Is the revised document something for industry to be thankful for? Let’s break it down:

  • Allowance for a phased-in, voluntary approach – This is something that many industry groups have been asking for, since the burden, as well as the complexity of collecting metrics from large,

12th Annual Scrip Awards

On November 30, 2016, the 12th Annual Scrip Awards will be held at the Grosvenor House Hotel, Park Lane, London. Lachman Consultants is proud to be a sponsor of the Executive of the Year category. We would like to congratulate all of the finalists in this category:

  • Eliot Forster, CEO of Immunocore
  • Mireille Gillings,

The Real Cost of Poor Data Integrity in Pharmaceutical Manufacturing

An article authored by Jim Davidson, Ph.D, Vice President, recently appeared in the July-August issue of Pharmaceutical Engineering. This very timely article, “The Real Cost of Poor Data Integrity in Pharmaceutical Manufacturing”, has also been the subject of White Papers authored by LCS, as well as the topic of numerous industry symposia. Congrats to Jim on a job well done!

Is FDA Starting to Think (Again) About Cloud Computing?

In April 2016, the FDA published its much-anticipated draft Guidance on Data Integrity. This Guidance is a great way for industry and FDA to start and continue the dialogue about data integrity. An interesting note about this Guidance is that buried, deep down on line 142, is a mention of “cloud infrastructure” as a “system” as it relates to “computer or related systems” in § 211.68. Up until this point, the FDA has been largely silent on the use of cloud computing for FDA regulated systems, and industry has taken this silence to be, in many ways, a prohibition to its use.