05
Nov
Keeping an Eye on The Ultimate Goal Image

Keeping an Eye on The Ultimate Goal – How to Ensure Success In Developing Complex Generics

One of the popular sessions in GRx+Biosims Conference held in Bethesda on November 4, 2019 was about Developing Complex Generic Products – How to Ensure Success. The session involved presentation and discussion by FDA and industry. Both sides agreed that the most important factor in assuring success in the development of complex generic is communication, […]

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10
Oct

Proactive Evaluation of Possible Genotoxic Impurities During the Early Stages of Drug Development

[vc_row][vc_column css=”.vc_custom_1570720331401{margin-bottom: 20px !important;}”][vc_column_text]Aloka Srinivasan, Vice President, Regulatory Practice at Lachman Consultants recently wrote an article for PharmTech, detailing the Proactive Evaluation of Possible Genotoxic Impurities During the Early Stages of Drug Development. The article provides a direction for identifying genotoxic impurities early in the drug development process, regulating genotoxic impurities at acceptable levels in […]

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09
Oct

Lachman Consultants to Show a Large Presence at the 2019 ISPE Annual Meeting & Expo

[vc_row][vc_column][vc_column_text] (Westbury, NY – October 2019) Lachman Consultant Services, Inc. (“Lachman Consultants”), a leading provider of expert compliance, regulatory affairs, and technical services to life sciences organizations worldwide, will return to the International Society for Pharmaceutical Engineering’s (ISPE) 2019 Annual Meeting. Lachman Consultants is sponsoring the event on October 27-30 and will be located in […]

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27
Aug

Effective Post Market Supplier Strategy for Combination Products

A combination product, which is a combination of a drug or biologic with a device delivery constituent part, are typically designed, developed, and maintained under a robust manufacturing process. This article is targeted for companies that have existing combination products on the market or are prepping their quality management systems to be compliant with the […]

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11
Jul

New FDA Guidance Released on Live Case Presentations for IDE Clinical Trials

We are living in a world that is constantly changing and using forms of media such as videos and live recordings as forms of communication, notification, training and archiving of special events.  In this age, we are constantly bombarded with Tweets, G-Chats and Facebook posts that have videos attached.  We can stream tv shows, live […]

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10
Jul

The Yellow Brick Road for Risk Evaluation and Mitigation Strategies

On July 9, 2019, FDA finalized the Guidance for Industry titled, Risk Evaluation and Mitigation Strategies: Modifications and Revisions.  The current Guidance updates the previous Guidance with the same name that was issued on April 7, 2015.  The update is more of a finalization; the portion of the draft that sets forth the submission procedures for […]

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14
Jun

FDA Webinar on Medical Device Q-Submissions; They Require Both Precision and Timing

On June 11, 2019, the FDA held a CDRH webinar on the Q-Submission Program for Medical Device Submissions.  The webinar was based on the recent May 7, 2019 Final Guidance document titled “Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program.”  This guidance document supersedes “Requests for Feedback on Medical Device Submissions: […]

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13
Feb

SaMD (Software as a Medical Device), Medical Device Design Control and the Need for US Guidance

I am currently attending the SDMD (Software Design for Medical Devices) Global IQPC conference in Berlin, where I presented on “Harmonization of Agile Methodology and Medical Device Design Control”.  This topic was chosen because, currently, there is no FDA Guidance on this issue, and to provide insight to developers to implement these systems using a […]

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06
Feb
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Are You at the Table, or On the Menu? Shouldn’t That Be an Easy Choice?

The annual meeting of AAM, Access 2019, is being held in the Hyatt Regency, New Orleans from February 4-6, 2019. The agenda of February 4th involved several sessions to be attended only by the members, including that of Science & Regulatory and Policy Working Group, and the Board Meeting.  The Science & Regulatory Team discussed […]

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