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Our Consultants at ASC LLC., are seasoned professionals in
the fields of Medical Device, IVD, Pharmaceutical, Biologics
and Combination Products. Our management has extensive
experience in interacting and advising Board and Executive
Leadership in Fortune 50 and other highly recognized
corporations in global, business, regulatory, compliance and
product development strategies. Certain key members of our
team are subject matter experts in Six Sigma, Design for Six
Sigma and New Product Development (concept to
commercialization) process.
SMITA GOPALASWAMY - PRESIDENT
An experienced Quality, Compliance and Regulatory
professional with more than nineteen years of leadership and
technical consulting responsibilities in Medical Device,
Biologics, Pharmaceutical Industries and Combination
Products. Her strong expertise in many regulatory and
compliance areas include FDA and ISO interactions and
audits, submissions and consulting, CE marking and device
certification, Quality systems Development and deployment,
New product development process, ISO, QSR’s, GLP, GCP,
Canada CMDR, Japan PAL, EU and other global regulatory
requirements.
Academic background includes a Ph.D/M.Phil, from University
of London, St. George's Hospital Medical School, UK;
Masters of Science in Biochemistry from the University of
London, Chelsea College, UK; a Bachelors of Science in
Applied Biology from the Thames Polytechnic, UK., and an
Executive Masters Degree in Business Administration from
Florida Atlantic University, School of Business.
the fields of Medical Device, IVD, Pharmaceutical, Biologics
and Combination Products. Our management has extensive
experience in interacting and advising Board and Executive
Leadership in Fortune 50 and other highly recognized
corporations in global, business, regulatory, compliance and
product development strategies. Certain key members of our
team are subject matter experts in Six Sigma, Design for Six
Sigma and New Product Development (concept to
commercialization) process.
SMITA GOPALASWAMY - PRESIDENT
An experienced Quality, Compliance and Regulatory
professional with more than nineteen years of leadership and
technical consulting responsibilities in Medical Device,
Biologics, Pharmaceutical Industries and Combination
Products. Her strong expertise in many regulatory and
compliance areas include FDA and ISO interactions and
audits, submissions and consulting, CE marking and device
certification, Quality systems Development and deployment,
New product development process, ISO, QSR’s, GLP, GCP,
Canada CMDR, Japan PAL, EU and other global regulatory
requirements.
Academic background includes a Ph.D/M.Phil, from University
of London, St. George's Hospital Medical School, UK;
Masters of Science in Biochemistry from the University of
London, Chelsea College, UK; a Bachelors of Science in
Applied Biology from the Thames Polytechnic, UK., and an
Executive Masters Degree in Business Administration from
Florida Atlantic University, School of Business.
Our Mission
© Advanced Solutions Consultants (ASC, LLC). All rights reserved.
| STAFF |
To provide complete solutions to Quality, Regulatory, New Product Development and Compliance challenges. We are dedicated in supporting our clients in the Device, Diagnostics, Pharmaceutical, Biologics and Combination Product industries in maintaining high standards of Quality in their practices and in their products. We encourage you to contact us for more information. |
| Contact us: Admin@ASC-FL.com 954-344-8284 |
