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Accomplished Global Pharma Executive Mary Oates Joins Lachman Consultants, Inc. as VP of Compliance Services

By | April 2, 2019 | News | Like |

(Westbury, NY – April 2, 2019) Fran Zipp, President and CEO of Lachman Consultants, Inc. a leading provider of compliance, regulatory affairs, and technical services to global life sciences organizations, today announced that Mary Oates has joined the firm as Vice President of Compliance Services. In her role, Oates will lead the expert team that comprises Lachman’s Compliance Practice Group,

Lachman Consultants Returns to ISPE Europe 2019

By | March 24, 2019 | News | Like |

(Westbury, NY – March 2019) On the heels of establishing a European based presence last year, Lachman Consultant Services, Inc., a leading provider of expert compliance, regulatory affairs, and technical services to life sciences organizations worldwide, will return to the ISPE Europe 2019 Annual Conference. Lachman is sponsoring the event on April 1-4,

Amy Schutte, new Senior Associate, Regulatory at Lachman Consultant Services, Inc.

By | March 21, 2019 | News | 2 |

We are pleased to announce that Amy Schutte has accepted the position of Senior Associate, Regulatory at Lachman Consultants, effective March 28, 2019. She will report to Aloka Srinivasan.

Ms. Schutte is a pharmaceutical industry professional with specialization in Regulatory Affairs and experience in quality, regulatory compliance, and pharmacovigilance. After nearly 20 years in the industry,

Tim Rhines, Ph.D., Joins Lachman Consultants as a Director in the Science and Technology Practice

By | March 11, 2019 | News | Like |

Timothy Rhines, Ph.D. is a Director in the Science & Technology Practice at Lachman Consultants who is a seasoned CMC pharmaceutical / biopharmaceutical professional with more than 27 years directing CMC activities, leading analytical chemistry teams, addressing compliance gaps, compliance department leadership with P&L responsibility, implementing process excellence initiatives, developing pharmaceutical product stability operations, and CMC project management.

Lachman Consultants to Offer Insights on Future Transition of Biological Products at the 2019 Parenteral Drug Association (PDA) Annual Meeting

By | March 1, 2019 | News | 1 |

(Westbury, NY – February 2019) Lachman Consultant Services, Inc., a leading provider of expert compliance, regulatory affairs and technical services to life sciences organizations worldwide will be a Bronze Sponsor at the 2019 Annual Meeting of the Parenteral Drug Association (PDA), Booth #308, March 11-13, at the Marriott Marquis San Diego, San Diego, CA. Themed “Solving Manufacturing and Supply Challenges for Current and Future Medicinal Products,” the PDA’s flagship Annual Meeting provides a venue for obtaining the latest information on parenteral processing,

Lachman Consultants Services, Inc. Announces Business Exposition Sponsorship of Access! 2019

By | January 24, 2019 | News | Like |

While concluding its 40th Anniversary Celebration Year with the start of 2019, Lachman Consultants recently announced participation as Business Exposition Sponsor of ACCESS! 2019, the annual meeting of the Association for Accessible Medicines (AAM).

(Westbury, NY – January 2019) Lachman Consultant Services, Inc. a leading provider of expert compliance, regulatory affairs and technical services to life sciences clients worldwide will be a prominent participant at ACCESS!

Happy Holidays from Us to You!

By | December 20, 2018 | ANDAs, Approvals, Bioequivalence, Biologics, Chemistry, Combination Products, Complex generics, Compliance, Compounding, Data Integrity, Dietary Supplements, eCTD, FDA, FDA, Generics, Guidance, Manufacturing, NDA, News, OTC, Regulatory Affairs, Science & Technology, Shortages, Training, Uncategorized, User Fees, Validation | Like |

To all of our readers – Have a happy holiday season and a very happy, healthy, and prosperous New Year.  The Lachman blog will be taking a break over the holiday starting Friday, December 21st (unless something extremely urgent occurs) and I hope that all of you will rejoin me in the New Year as we follow the ever-changing landscape of FDA regulatory science,

Fran Zipp Elected Vice Chair of ISPE International Board of Directors

By | October 3, 2018 | News | 2 |

LCS would like to congratulate the newly elected International Board of Directors for ISPE for 2018-2019. This Board is responsible for devising strategy and governance of ISPE, the International Society for Pharmaceutical Engineering, is the world’s largest not-for-profit association serving its Members by leading scientific, technical and regulatory advancement throughout the entire pharmaceutical lifecycle. The newly elected Board includes LCS’ own CEO and President,

Keith Webber, Ph.D., new Vice President, Biotechnology at Lachman Consultant Services, Inc.

By | August 31, 2018 | News | Like |

We are pleased to announce that Keith Webber, Ph.D. has accepted the position of Vice President, Biotechnology at Lachman Consultants, effective September 1, 2018.

Dr. Webber delivers scientific direction, strategic guidance, and leadership regarding biotechnology products, new drugs, and generic drugs, based on his 30+ years of combined industry, U.S. FDA, and NIH experience. 

Lori-Ann Woodard, new Director, Medical Device at Lachman Consultant Services, Inc.

By | August 19, 2018 | News | Like |

We are pleased to announce that Lori-Ann Woodard has accepted the position of Director, Medical Device at Lachman Consultants, effective August 20, 2018.

Ms. Woodard delivers expertise in the implementation and management of Quality Management Systems for medical devices, Software as a Medical Device (SaMD), and combination products. She has more than 20 years of experience that includes building QMS and cGMP quality systems from the ground up,

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