News

In her new role, Linda will directly support the President and CEO serving as principal interface in key matters and delivering oversight across all Practice Areas, including program management of existing, new, and evolving projects. She will assist in the development of strategic plans and goals, advise on projects and critical issues, and continue to […]

On May 3, 2018 at the Food Drug and Law Institute’s Annual Conference, LCS’ President and CEO Fran Zipp participated in a panel with CDER Director Janet Woodcock. Other panelists included Margaret Anderson (Deloitte), Daniel Kracov (Arnold & Porter LLP), and Peter Pitts (Center for Medicine in the Public Interest), moderated by Carla Cartwright (JnJ).  […]

We are pleased to announce that Donna Gulbinski has accepted the position of Vice President, Compliance Services at Lachman Consultants, effective April 9, 2018.  In this new role, Donna will report directly to me. Ms. Gulbinski is a proven global quality leader who delivers strategic quality, compliance, and business performance services to Lachman and our […]

We are pleased to announce that Constance Richard-Math has accepted the position of Director in the Compliance Practice at Lachman Consultants. Constance Richard-Math joined Lachman Consultants after a 20-year career at the U.S. Food and Drug Administration where she rose to the position of Director, Investigations Branch at the Baltimore, Maryland District Office. While at […]

Lachman Consultant Services’ Ricki Chase sees too many companies falling down on design control activities when they set out to make combination device/drug products. Check out what she said here.

Join former FDA Investigations Branch Director Ricki Chase – now with Lachman Consultants – as she draws on her 16 years of agency experience to bring you the latest insights into the complexity surrounding combination device/drug products.

Too many medical device manufacturers are struggling because they don’t have policies and systems in place to handle the ever-growing amount of data they receive about their products once they’ve gone to market. As a result, important signals can go undetected or unaddressed, leading to compliance problems and devices that are of poor quality – […]

In today’s global marketplace, industry is responsible for adhering to regulations in all markets that their products are in. Today’s pharmaceutical supply chain also likely contains partners that are across many geographic regions, and regulators expect conformity. In addition, regulators expect proactive compliance, and concerns about a retroactive “lack of assurance” of GMP are frequently […]

We are pleased to announce that Janis Picurro has accepted the position of Principal Consultant in the Regulatory Practice at Lachman Consultants, effective December 18, 2017. Ms. Picurro is a senior level regulatory professional with over 24 years of experience in the pharmaceutical industry where she had a career of progressively increasing responsibilities in Regulatory […]

We are pleased to announce that Lisa Tinsley has accepted the position of Director in the Compliance Practice at Lachman Consultants, effective December 1, 2017. Ms. Tinsley is a 25-year pharmaceutical compliance and remediation professional who has led global compliance and auditing teams, developed Quality leadership and strategies, and enhanced Quality Systems. She is well […]