04
May

New Webinar Series From Lachman Consultants Provides Valuable Information To The Pharmaceutical Industry

(Westbury, NY— April 2019) Lachman Consultant Services, Inc. (Lachman Consultants) will be launching a new webinar series beginning with “Preparing for and Handling an FDA Inspection” on Thursday, May 14th at 2:00 pm EDT. Ever a responsive and supportive partner to its clients, these webinars are Lachman Consultants latest effort in providing timely and critical […]

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27
Apr

Lachman Consultants New Webinar Series Provides Timely and Valuable Information To The Pharmaceutical Industry

Lachman Consultant Services, Inc. (Lachman Consultants) is helping you to navigate the ever-changing economic and business environment with our new webinar series. During these times of social distancing and working remotely from home, these webinars are Lachman Consultants latest way of providing you with up-to-the-minute, valuable information to about a wide range of topics that […]

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27
Apr

FDA Launches Webpage on COVID-19-Related Guidance Documents for Industry, FDA Staff, and Other Stakeholders

FDA recently launched a comprehensive listing of COVID-19 related guidance documents, which can be found here.  Tracking all COVID 19 related documents can be daunting, as the content is being issued at a fast and furious rate, and this website will make that task a little less onerous. The list is filterable, sortable, and can […]

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27
Apr

Lachman COVID-19 Survey Provides Interesting Insights

Lachman Consultants recently conducted a survey of professionals working in the pharmaceutical, biotechnology, medical device, and other regulated sectors related to the greater life sciences industry with the goal of taking the “pulse” of the overall organizational and industry impact of the COVID-19 pandemic. The results of the survey can be found here. A few […]

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24
Apr

Impact of COVID-19 on European Inspections

The European Commission, the European Medicines Agency (EMA), and national competent authorities have recently issued an updated Question and Answers document on Regulatory Expectations for Medicinal Products for Human use during the COVID-19 Pandemic.  The guidance can be found here. The guidance covers the following topics: Issues related to marketing authorizations, marketing authorizations procedures Manufacturing, […]

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23
Apr

Lachman Consultants COVID-19 Survey Results

From March 31 through April 14, 2020, Lachman Consultant Services, Inc. (Lachman Consultants) conducted a voluntary survey of professionals working in the pharmaceutical, biotechnology, medical device and other sectors related to the greater life sciences industry. The purpose of the survey was to take a “pulse” of the overall organizational and industry impact of the […]

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13
Apr

Lachman Consultants Offers Support to Help U.S. Distilleries and Breweries Manufacture Hand Sanitizer

(Westbury, NY – April 6, 2020) For industries not accustomed to working with the FDA or interpreting FDA regulations and guidance in the manufacture of hand sanitizers, this can be a challenging time. In support of these companies’ efforts to aid in stemming the advance of COVID-19, Lachman Consultant Services, Inc. (“Lachman Consultants”) is reaching […]

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09
Apr

COVID-19 and Shortage-Related Requests for Manufacturing Process and Site Changes

On April 7, 2020, FDA released a Q&A on manufacturing and supply change requests related to COVID-19 and drug shortages.  In this Q&A, FDA provided the following guidance:   Manufacturing site changes because of supply chain disruptions related to COVID-19 – If the site change is for treatment of patients with COVID-19 or for drugs […]

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07
Apr

Regulatory Intelligence

How do companies keep up with the rapidly changing world of drug and device regulations?  Some companies have entire departments dedicated to these efforts.  Other companies have people doing it part-time, perhaps as an add-on to their primary jobs.  Some companies may not pay attention at all. Lachman offers a solution to this.  We develop […]

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