Pete Manger, Author at Lachman Consultant Services, Inc.

Lachman Consultants’ Team Teaches Young Professionals How Properly Preparing For and Addressing FDA Form 483 Ultimately Helps Save Patient’s Lives

By Pete Manger Nov 11, 2019 News

(Westbury, NY – November 2019) Spanning approximately 120 minutes, part of the executive team from Lachman Consultant Services, Inc. (“Lachman Consultants”) guided 45 young professional engineers and chemists through an introduction to current Good Manufacturing Practices (“cGMP”) during ISPE’s 2019 Annual Meeting. As a leading provider of expert compliance, regulatory affairs and technical services to […]

Nov

The Answers May be in What Is Not Stated Image

The Answers May be in What Is Not Stated – Drug Substance and Drug Product Manufacturers – Partnering to Improve the Process

By Pete Manger Nov 06, 2019 ANDAs FDA Regulatory Affairs Science & Technology

An interesting session during the GRx+Biosims conference held in Bethesda on November 4, 2019 addressed Drug Substance and Drug Product Manufacturers – Partnering to Improve the Process. The presentations from the FDA, as well as industry, acknowledged that the adequacy of drug master files (DMFs) for APIs in one cycle has been a lot more […]

Nov

Your Thoughts From The 2019 ISPE Annual Meeting

By Pete Manger Nov 05, 2019 Compliance Data Integrity Regulatory Affairs

While attending the 2019 ISPE Annual Meeting in Las Vegas we asked our booth visitors to answer two questions that help gauge the industry in a top-of-mind way. We asked for insight into what is currently on their mind as an organization, and what their biggest takeaways from the event are. This year, it was […]

Nov

Keeping an Eye on The Ultimate Goal Image

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

By Pete Manger Nov 05, 2019 Complex Generics FDA Generics Regulatory Affairs Science & Technology

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, […]

Oct

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

By Pete Manger Oct 10, 2019 FDA NDA Regulatory Affairs Science & Technology

[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 […]

Oct

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

By Pete Manger Oct 09, 2019 News

[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 […]

Aug

Effective Post Market Supplier Strategy for Combination Products

By Pete Manger Aug 27, 2019 Combination Products FDA Generics

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 […]

Jul

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

By Pete Manger Jul 11, 2019 Clinical Compliance FDA Guidance Safety Uncategorized

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 […]

Jul

The Yellow Brick Road for Risk Evaluation and Mitigation Strategies

By Pete Manger Jul 10, 2019 ANDAs BLA FDA Generics NDA Regulatory Affairs

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 […]

Jun

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

By Pete Manger Jun 14, 2019 FDA Medical Devices Regulatory Affairs

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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