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ASC LLC., is a consulting service provider in business
and technical solutions to Quality, Compliance and
Regulatory requirements, Product Development for
Medical Device, Diagnostics, Biologics, and
Pharmaceutical companies.
We provide strategy consulting and leadership coaching
to enable Quality/ Regulatory leaders be more effective.
In addition, consultation is provided in the areas of
Product Innovation and Development, Combination
Products, Six Sigma, and Design for Six Sigma.
Our expertise includes regulatory, compliance, quality,
new product development, Strategy development, FDA's
Good Manufacturing Practices, CGMP’s, GCP’s and
training support. Strong technical support is provided by
individuals with extensive regulatory, FDA, ISO, Canada
CMDR, Japan PAL compliance knowledge and
experience in Medical Device, Diagnostics
Pharmaceutical and Biotech industries. We are
experienced in Class I, II, and III devices and have
extensive expertise in combination products.
We specialize in the preparation and review of regulatory
applications (INDs and BLAs, PMA’s, 510k’s) as well as
the inspection/audit of manufacturing facilities for
processes and systems.
Because of our familiarity with the FDA, Canada,
European, Japan and Emerging Market Standards, we
can enable our clients to overcome various challenges
faced today in regulated industries. Solution oriented
advice, support, training and coaching is provided on
Strategy, New Product Development Systems, Quality
Systems, Manufacturing Systems, Six Sigma/ DFSS
projects, Facility Inspections, Program Management,
Clinical Trial Design and Evaluation.
and technical solutions to Quality, Compliance and
Regulatory requirements, Product Development for
Medical Device, Diagnostics, Biologics, and
Pharmaceutical companies.
We provide strategy consulting and leadership coaching
to enable Quality/ Regulatory leaders be more effective.
In addition, consultation is provided in the areas of
Product Innovation and Development, Combination
Products, Six Sigma, and Design for Six Sigma.
Our expertise includes regulatory, compliance, quality,
new product development, Strategy development, FDA's
Good Manufacturing Practices, CGMP’s, GCP’s and
training support. Strong technical support is provided by
individuals with extensive regulatory, FDA, ISO, Canada
CMDR, Japan PAL compliance knowledge and
experience in Medical Device, Diagnostics
Pharmaceutical and Biotech industries. We are
experienced in Class I, II, and III devices and have
extensive expertise in combination products.
We specialize in the preparation and review of regulatory
applications (INDs and BLAs, PMA’s, 510k’s) as well as
the inspection/audit of manufacturing facilities for
processes and systems.
Because of our familiarity with the FDA, Canada,
European, Japan and Emerging Market Standards, we
can enable our clients to overcome various challenges
faced today in regulated industries. Solution oriented
advice, support, training and coaching is provided on
Strategy, New Product Development Systems, Quality
Systems, Manufacturing Systems, Six Sigma/ DFSS
projects, Facility Inspections, Program Management,
Clinical Trial Design and Evaluation.
Our Mission
© Advanced Solutions Consultants (ASC, LLC). All rights reserved.
| ABOUT US |
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 |
