Advertisement
WESTBURY, N.Y., March 1, 2019 /PRNewswire-PRWeb/ -- 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, manufacturing, supply chain and quality control.
On the minds of those attending the meeting will be a recent regulation which will transition biological products to be considered as 'biologics' rather than 'new drugs' under the Federal Food, Drug and Cosmetic Act. The category transition is to be fully complied with by March of 2020. Initially passed in 2010 as part of the Patient Protection and Affordable Care Act, the Biologics Price Competition and Innovations Act codifies the ability of the Food and Drug Administration (FDA) to review and approve biosimilar medicinal products.
"Although March 20, 2020 may seem a long way off, compliance with these new regulations requires a disciplined and well-informed program. A timely approach to pro-actively navigating their complexities is essential," comments Keith Webber, Ph. D., Vice President, Biotechnology at Lachman. "Our consultants are well-versed and equipped with the knowledge and expertise to guide companies on the pre- and post-approval requirements in order to be prepared for the change and minimize any delay of approval of their applications and supplements."
Lachman Consultants brings both experience and excellence to its Biopharmaceutical and Biotechnology Consultation Services. Through its dedicated single point of contact approach, multi-disciplinary groups of accomplished FDA and industry experts are assembled from the firm's Compliance, Regulatory, and Science and Technology Practice Groups. These comprehensive teams are selected and assigned according to each client's unique set of objectives, needs and circumstances.
Visitors to the Lachman Consultants booth will have the opportunity to meet with company executives and senior consultants to gain valuable insight about the company's services for pharmaceutical/biopharmaceutical manufacturing, science and regulation. In addition to Webber, in attendance will be Fran Zipp, President & CEO, and Linda Evans O'Connor, Vice President & Chief of Staff, as well as several other members of the Lachman Consultants team.
# # # #
ABOUT LACHMAN CONSULTANTS
Founded in 1978, Lachman Consultants maintains three practice groups: Compliance, Regulatory Affairs and Science and Technology. Each practice offers industry-leading experience and expertise in its area of focus. Lachman Consultants serves emerging-to-enterprise organizations on a worldwide basis in the Pharmaceutical, Biotechnology, Biologics, Device and Related Life Science Industries. Lachman Consultants deliver solutions that include FDA-Related Services, Audits, Quality Assurance & Controls, Scientific and Technical Assistance, Systems Evaluation, Facilities Design or Validation System & Process Validation or Qualification and Training, which consistently exceed client requirements and expectations.
For additional press information, please contact: Ilena Della Ventura Delia Associates T. 908-534-9044 E. Idellaventura(at)delianet.com
SOURCE Lachman Consultants Services, Inc.
Advertisement
On the minds of those attending the meeting will be a recent regulation which will transition biological products to be considered as 'biologics' rather than 'new drugs' under the Federal Food, Drug and Cosmetic Act. The category transition is to be fully complied with by March of 2020. Initially passed in 2010 as part of the Patient Protection and Affordable Care Act, the Biologics Price Competition and Innovations Act codifies the ability of the Food and Drug Administration (FDA) to review and approve biosimilar medicinal products.
"Although March 20, 2020 may seem a long way off, compliance with these new regulations requires a disciplined and well-informed program. A timely approach to pro-actively navigating their complexities is essential," comments Keith Webber, Ph. D., Vice President, Biotechnology at Lachman. "Our consultants are well-versed and equipped with the knowledge and expertise to guide companies on the pre- and post-approval requirements in order to be prepared for the change and minimize any delay of approval of their applications and supplements."
Lachman Consultants brings both experience and excellence to its Biopharmaceutical and Biotechnology Consultation Services. Through its dedicated single point of contact approach, multi-disciplinary groups of accomplished FDA and industry experts are assembled from the firm's Compliance, Regulatory, and Science and Technology Practice Groups. These comprehensive teams are selected and assigned according to each client's unique set of objectives, needs and circumstances.
Visitors to the Lachman Consultants booth will have the opportunity to meet with company executives and senior consultants to gain valuable insight about the company's services for pharmaceutical/biopharmaceutical manufacturing, science and regulation. In addition to Webber, in attendance will be Fran Zipp, President & CEO, and Linda Evans O'Connor, Vice President & Chief of Staff, as well as several other members of the Lachman Consultants team.
# # # #
ABOUT LACHMAN CONSULTANTS
Founded in 1978, Lachman Consultants maintains three practice groups: Compliance, Regulatory Affairs and Science and Technology. Each practice offers industry-leading experience and expertise in its area of focus. Lachman Consultants serves emerging-to-enterprise organizations on a worldwide basis in the Pharmaceutical, Biotechnology, Biologics, Device and Related Life Science Industries. Lachman Consultants deliver solutions that include FDA-Related Services, Audits, Quality Assurance & Controls, Scientific and Technical Assistance, Systems Evaluation, Facilities Design or Validation System & Process Validation or Qualification and Training, which consistently exceed client requirements and expectations.
For additional press information, please contact: Ilena Della Ventura Delia Associates T. 908-534-9044 E. Idellaventura(at)delianet.com
SOURCE Lachman Consultants Services, Inc.
