GET EXPERT ADVICE AT MEDTECH FORUM 2022 After four years in the works, the U.S. Food and Drug Administration (FDA) has finally published their much-anticipated proposed rule (PR) to amend the Quality System Regulation (QSR) (21 CFR Part 820) on 2/23/2022. This proposed rule not only impacts U.S. manufacturers but all manufacturers with product in […]
As the combination products market continues to expand at a rapid pace, pharmaceutical and biotech companies need to be one step ahead as they bring new combination products and technologies to market. Manufacturers need to think about their products in a new way as they consider not just the drug itself, but also the design […]
Join Frances Zipp, President and CEO of Lachman Consultant Services, Inc., at the AAM Annual Conference, Access! 2022, where she will moderate the WiHP Healthcare Leadership luncheon. The panel discussion will be held on February 15, 2022, at 12:30 pm. Frances will be joined by AMCP CEO Susan Cantrell, AHIP’s EVP of Government Affairs and […]
Join Frances Zipp, President and CEO of Lachman Consultant Services, Inc., at the AAM Annual Conference, Access! 2022, where she will moderate the WiHP Healthcare Leadership luncheon. The panel discussion will be held on February 15, 2022, at 12:30 pm. Frances will be joined by AMCP CEO Susan Cantrell, AHIP’s EVP of Government Affairs and […]
Data integrity is an ever-increasing concern in the life sciences as evidenced by the recent activities of the FDA placing its watchful eye on the evolving medical device industry. To help manufacturers better understand, establish, and maintain data integrity under growing regulatory scrutiny, Lachman Consultant Services, Inc. (Lachman Consultants) hosted a free webinar on Wednesday, […]
Join Lachman Consultant Services, Inc. (Lachman Consultants) at the GRx+Biosims 2021 virtual event for three days of timely insights, peer networking, and unique content geared toward technical, regulatory, and policy professionals in the U.S. generics and biosimilars industry. Held from November 8 – 10, the widely acclaimed event will bring together top officials and subject-matter […]
We are pleased to announce that Lachman Consultants will once again participate in the ISPE Annual Meeting & Expo. This event will be held at the Hynes Convention Center in Boston, MA, from October 31 – November 3, Booth #1033. Lachman attendees include: Fran Zipp, President and CEO Linda Evans O’Connor, Vice President, Chief of […]
Today, the FDA issued a third revision of a draft guidance titled Hospital and Health System Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act (here). The Agency revised this guidance, which was previously revised in June 2016, in response to comments submitted to that document. The revised document describes how and […]
The Key Role of Off Patent Medicines: Fran Zipp, President and CEO of Lachman Consultant Services, Inc., will be a moderator on Session- 6 OFF-PATENT ROLE FOR GLOBAL HEALTH: PUTTING PATIENTS FIRST, at the Annual Medicines for Europe and IGBA Conference in Athens, Greece on October 6-8, 2021. The agenda includes bridging the access gap […]
(Westbury, NY— November 2020) Lachman Consultant Services, Inc. (Lachman Consultants), a provider of compliance, regulatory, and technical consulting services to the global pharmaceutical and related industries, was recently named a “Top-Ten Medical Device Consulting Company” by highly-regarded, industry publication MedTech Outlook. In making the announcement in its September issue, the monthly periodical outlined that its […]
