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 […]
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 […]
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 […]
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, […]
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 […]
Survey closes 5:00pm EDT on Tuesday, April 14th! Lachman Consultant Services, Inc. is surveying the impact of COVID-19 on the Global Life Sciences Industry. Please take a moment to complete this brief survey as we take a “pulse” on the impact of COVID-19 on your organization. LAUNCH THE SURVEY We sincerely appreciate your input […]
(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 […]
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 […]
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 […]
Training of employees remains a hallmark of the industry’s ability to deliver high quality medicines, devices, and diagnostics. Training is a crucial activity, now, more than ever, in this rapidly changing environment. During this period of social distancing, when the experts cannot travel to your site to perform training, that does not mean that this […]
