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Since 1978, Lachman Consultants’ multidisciplinary team of highly experienced FDA and industry experts has offered compliance, regulatory affairs, and technical services to clients around the world.
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Our blogs feature and report on the latest news and trends in the industry.
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Latest Blogs

Finally, Someone Else Gets It!  Am I Wrong???

As I read the article “Prescription-drug policy: Don’t throw the bed out with bedpan”, written by Jim Waters in the Bluegrass Institute (here) about the “Pay-for-Delay issue, I harkened back to a position I took in a very old FTC law suit (that FTC won) and thought – well, someone else gets it!

Laboratory Instrument Calibration – Are You Covered?

It is paramount that a Quality Control laboratory has a calibration and preventative maintenance program for the laboratory instrumentation so that there is assurance that the instrumentation continues to be “fit for purpose” and that there is confidence in the accuracy and reliability of all analytical instruments.  There should be a controlled, comprehensive list of the instrumentation within the laboratory,

More is Not Always Better – Extra Testing

When it comes to ice cream and desserts, I must admit the more the better in my opinion.  The same, however, doesn’t hold true for laboratory testing and the resultant data.  All testing performed and data generated must be accountable to ensure the integrity of the data.  Performing extra testing, even if with all good intentions,

Child-Resistant Packaging – The FDA Outlines What and How to Label Products

In a Federal Register announcement today (here), the FDA announced the availability of a final guidance entitled Child-Resistant Packaging Statements in Drug Product Labeling.  The guidance provides information on the type of statement that may be made on child-resistant packaging for drug products.

As a reminder, the FDA has not regulated child-resistant packaging since 1973,

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Latest News

Frances Zipp of Lachman Consultants to be Featured Speaker at Annual Medicines for Europe Conference

(Westbury, NY – May 2019) Lachman Consultant Services, Inc. (“Lachman Consultants”), a leading provider of expert compliance, regulatory affairs and technical services to life sciences clients worldwide, will be participating as a Conference Sponsor at the 25th annual Medicines for Europe and IGBA Conference. Entitled “Committing to Global Health – Balancing Access and Sustainability,” this year’s event is focused on generic,

Accomplished Global Pharma Executive Mary Oates Joins Lachman Consultants, Inc. as VP of Compliance Services

(Westbury, NY – April 2, 2019) 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 Mary Oates has joined the firm as Vice President of Compliance Services. In her role, Oates will lead the expert team that comprises Lachman’s Compliance Practice Group,