“Establishing mutually-beneficial partnerships is a key factor in achieving maximum operational productivity." - Frances Zipp, President & CEO of Lachman Consultants
WESTBURY, N.Y. (PRWEB) May 29, 2019
Frances Zipp, President & CEO of Lachman Consultants, will be speaking on Thursday, June 13th at 11:30 a.m. at the conference. Her presentation will be on the topic of Efficiency Gains Through International Regulatory Collaboration. “Establishing mutually-beneficial partnerships is a key factor in achieving maximum operational productivity,” states Ms. Zipp. “I look forward to sharing the knowledge and expertise that more than three decades in the Life Sciences has afforded me.” A question and answer session will follow the presentation.
The conference brings together more than 300 experts, including manufacturers, stakeholders, and governments to evaluate market trends, innovative commercial strategies, challenges for the pharma sector and new opportunities to improve access to medicines for patients. Medicines For Europe will take place in Warsaw, Poland from June 12-14, at the Sofitel Warsaw Victoria. Attendees are invited to visit with Lachman Consultants on the show floor.
Lachman Consultants attendance at the annual event will be of special interest to attendees as the firm has an established presence across the European continent and is extremely well versed in both U.S. and European compliance in all aspects, including manufacturing and facilities. In addition, Lachman Consultants offers decades of experience, working with generics companies, both past and present, on a worldwide basis, gaining a deep understanding of the FDA Generics landscape in the process. The company also specializes in helping Life Science companies break into the FDA and U.S. markets by serving a broad range of compliance and regulatory needs.
A FULL MENU OF GENERIC AND BIOSIMILAR SERVICES
The robust service capabilities for generics and biosimilars of Lachman Consultants are focused in three areas: Compliance, Regulatory Affairs, and Science & Technology. Lachman’s consultants are accomplished, experienced and highly accurate in their recommendations resulting in more timely approvals of applications and submissions. The organization is well-positioned to provide consultation and full development support for therapeutically equivalent products, from small molecules to complex biologics to combination products.
“Working on behalf of international clients, we have the ability to act as U.S. agents and proactive partners to offshore entities, assisting them in communications and interactions with the U.S. Food and Drug Administration,” adds Ms. Zipp. Experts in 505(b)(2) submissions and ANDAs, Lachman Consultants works closely with sponsors in determining the most effective communication strategies and procedures regarding regulatory questions as well as the myriad of ways regulations affect submissions.
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ABOUT FRANCES M. ZIPP – PRESIDENT & CEO OF LACHMAN CONSULTANTS
Fran Zipp is the President & CEO of Lachman Consultants who provides expert guidance to the pharmaceutical, biologic and biotechnology industries. Ms. Zipp joined Lachman after a 30-year career in the industry, where she held significant positions of responsibility for Quality and GxP Compliance, including various positions in drug development, operations, quality, and regulatory affairs. Ms. Zipp delivers the strategic guidance and direction toward the implementation of effective solutions to client needs. As an expert in compliance enhancement, she develops program solutions to meet GXP compliance requirements and works with industry senior management to restore healthy company relationships with regulatory authorities. Ms. Zipp has extensive experience covering the entire spectrum from R&D through post-marketing surveillance. She assists and counsels senior-level management in areas of Corporate Governance, Due Diligence evaluations (facilities; products; technologies), and provides leadership, direction, and management of the Lachman Consultants’ consulting operations as well as corporate services including legal and financial services and administration.
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 delivers solutions that include FDA-Related Services, Audits, Quality Assurance & Controls, Scientific and Technical Assistance, Systems Evaluation, and Training, which consistently exceed client requirements and expectations.
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Ilena Della Ventura