Aloka Srinivasan, Ph.D., New Vice President, Regulatory Practice at Lachman Consultant Services, Inc.

We are pleased to announce that Aloka Srinivasan has accepted the position of Vice President, Regulatory Practice at Lachman Consultants, effective May 14, 2018.

Dr. Srinivasan is a recognized professional with more than 15 years of experience serving at FDA and National Cancer Institute where she contributed to: establishing a DMF review division in FDA to meet GDUFA related goals;

We are pleased to announce that Linda Evans O’Connor has been promoted to VP, Chief of Staff.

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 direct the on-going development of the Lachman brand and marketing strategy.

Donna Gulbinski, new Vice President, Compliance Services at Lachman Consultant Services, Inc.

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 clients. 

Constance Richard-Math, new Director at Lachman Consultant Services, Inc.

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.

From Big Data To Cybersecurity, Today’s Device-Makers Face Myriad Compliance Risks – But Being Proactive Can Pay Off, Ex-FDA Official Says – article in Medtech Insight by Lachman Consultants

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 – both of which could ultimately affect a device-maker’s bottom line.

Anticipating trends in regulation – how do you get your information, and what do you do with it once you do?

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 the cause of a recall. 

Janis Picurro, new Principal Consultant at Lachman Consultant Services, Inc.

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 Affairs.

Lisa Tinsley, new Director at Lachman Consultant Services, Inc.

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 experienced with FDA inspection requirements,

Jose L. Toro, Ph.D., new Principal Consultant at Lachman Consultant Services, Inc.

We are pleased to announce that Jose L. Toro has accepted the position of Principal Consultant in the Compliance Practice at Lachman Consultants, effective November 13, 2017.

Dr. Toro has extensive R&D Quality, and Quality Operations experience in the pharmaceutical industry.
He specializes in the transformation of Quality and Technical Services organizations including Quality Systems,

Ricki Chase, M.S., Director, Lachman Consultants, to Present at American Pharma Outsourcing Summit

Ricki Chase, Director, Compliance Practice, will be presenting at the American Pharma Outsourcing Summit taking place September 27th and 28th, 2017 at the Doubletree by Hilton Boston North Shore. Ricki will be presenting on the Regulatory Hazards of Outsourcing, and will cover the following areas:

  • Approving products on a batch-by-batch basis
  • Establishing laboratory controls
  • Training employees in current GMPs
  • Having appropriate test procedures designed to assure standards
  • Examining compliance services that are available to you

Her presentation will be taking place on Tuesday,