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George Toscano is listed as President at TCG at Toscano Consulting Group, based in Fort Lauderdale, Florida, United States. AeroLeads shows a work email signal at nsf.org and a matched LinkedIn profile for George Toscano.
George Toscano previously worked as President at Toscano Consulting Group and Vice President, Quality Systems, NSF Health Sciences Pharmaceutical and Biologics at Nsf Health Sciences. George Toscano holds Mba, International Business from Florida Atlantic University.
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Mr. Toscano has served as project manager and expert consultant on large complex international compliance projects involving corporate 483 responses, Warning Letters, Consent Decree(s), and AIP. He has provided clients with expert counsel on laboratory and manufacturing investigations, CAPA development and implementation, change control, training, stability programs and other quality systems. He is a recognized Data Integrity expert and has been involved in numerous audits and assessment to evaluate companies systems. In addition, he has assisted companies with remediation activities related to Data Integrity deficiencies and enforcement actions.Mr. Toscano has managed analytical R&D laboratories and has extensive knowledge of product development, method development, validation and transfer. He has served as project lead for large scale international method transfer projects. Mr. Toscano has managed or overseen product development and the generation of CMC sections for regulatory submissions of ANDA's, NDA's and 505(b)2 applications. Most recently he was project lead for a multi-year facility expansion and remediation project for a major Biologics manufacturer under consent decree with a successful outcome for the client.Mr. Toscano has over 25 years of industry experience working in quality assurance, data integrity, 21 CFR Part 11, validation, vendor qualification, auditing, batch record review, product release and stability, investigation of non-conformances, cGMP training, senior management and facility expansion. His technical background and broad range of experience has proven essential in providing clients strategies for the implementation and remediation of quality systems to comply with FDA regulations.
Listed skills include Fda, Gmp, Validation, Pharmaceutical Industry, and 46 others.
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TCG provides quality and regulatory consulting services to the Pharmaceutical, Biologics and Medical Device Industries. Our services Include Auditing, Gap Assessments, Regulatory strategy and submission support, due diligence support and response to FDA enforcement actions including: 483s, Warning Letters, Consent Decrees (permanent injunctions), AIP.
Ann Arbor, Michigan, US
Ann Arbor, Michigan, US
Durham, North Carolina, US
U.S. project lead for large-scale multi laboratory sampling and testing effort as part of AIP response to FDA. Formulated sampling plan based on product therapeutic significance, quality and AQL metrics. Coordinated complete testing effort at all U.S. sites.·Worked with foreign and domestic clients in the pharmaceutical, medical device and biotechnology.
NZ
A key member of the upper management team responsible for the decision to pursue prospective drug candidates based on product feasibility, market potential and regulatory pathway. Involved in financial activities including preparing financial and operational statements and performing company valuations based on multiples valuation approach of comparable.
US
Director of Pharmaceutical, Biotechnology and Medical Device Business Unit. ·Lead a group consisting of a Research Manager and a team of researchers to fulfill client needs for Major Pharmaceutical, Biotech and Medical Device companies within the Life sciences space. ·Responsible for the negotiation of pricing and contract structure with clients for.
NZ
Responsible for the management of laboratory functions, processes and personnel. Played vital role in bringing a company under consent decree back in to compliance with cGMP issues and FDA regulations. Developed and implemented internal policies to aid the company with the re-launch of products. Implemented sample stability program and method validation.
US
Responsible for the management of the analytical activities in preparation for ‘first to file’ ANDA opportunities with multi million dollar revenue potential. Setup the analytical laboratory layout and procured the requisite initial laboratory equipment from vendors.Create and implement policies for handling of Schedule II-V controlled substances in.
Miami, Florida, US
Management of the method development process in accordance with FDA and various regulatory agencies. Routinely resolved investigations from the Quality Control group by working in conjunction with technical services group. Method development and validation of stability indicating HPLC methodology for Transdermal drug products.Execute validation protocols.
CA
Developed procedures and testing guidelines for product formulations in accordance with FDA, USP and ICH guidelines. Trained new chemists and managed Quality Control investigations. Provided drug stability profile on product formulations to select prospective drug candidatesDeveloped and validated HPLC stability indicating testing methodology for clients.
Miramar, FL, US
Managed group of analysts responsible for clinical trials testing. Developed physical testing methods as well as analyzing products, methods supported new ANDA’s and NDA’s for transdermal drug applications supporting, drug applications which are the chief source of revenue.Trained clinical group in all aspects of finished product and raw materials testing.
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George Toscano works for Toscano Consulting Group.
George Toscano is listed as President at TCG at Toscano Consulting Group.
AeroLeads has found 1 work email signal at @nsf.org for George Toscano at Toscano Consulting Group.
George Toscano is based in Fort Lauderdale, Florida, United States while working with Toscano Consulting Group.
George Toscano has worked for Toscano Consulting Group, Nsf Health Sciences, George Toscano Consulting Inc, Becker & Associates Consulting, Inc., and Quintiles.
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George Toscano holds Mba, International Business from Florida Atlantic University.
George Toscano is listed with skills including Fda, Gmp, Validation, Pharmaceutical Industry, Sop, Biotechnology, Capa, and Quality Assurance.
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