Effective use of
resources is key to efficient drug development.
Having been in the industry since 1990, Sandy’s
experience and network facilitate quick
identification of resources a client may need,
beyond those Hecker & Associates can provide
directly.
Sandy’s experience managing regulatory
submission contractors at Genentech, and
managing submission writing regulatory groups at
four (thanks to mergers) Contract Research
Organizations (CROs) enabled her to identify
best practices she uses now to support Hecker
& Associates’ clients most effectively.
These include:
-Keeping up to date on US regulatory
requirements—regulations and guidelines, as well
as the unwritten expectations of FDA, based on
her experience or that of her colleagues in her
professional society networks. (Anyone can read
regulations and guidelines, but only those
experienced working with them know the various
levels at which they apply, in the view of the
regulatory authorities.)
-Integrating herself (and any other project
expertise needed) so well into the client team,
the client understands that Sandy cares as much
about the success of the client’s project(s), as
the client, which facilitates effective project
communication.
-Anticipating potential regulatory issues, and
alerting a client to them, before they become
too large to resolve easily.
-Ensuring the ability to handle unexpected
expansion of a project’s scope, without delaying
the project.
-Maintaining professional society networks of
expertise to discuss best practices based on
recent experience for handling any eventuality,
from changing requirements for safety reporting
in clinical trials to meeting myriad clinical
trial disclosure requirements, to ensure
efficient global work.
-Her close proximity to FDA enables Sandy to
attend FDA public meetings and FDA Advisory
Committee meetings for information to benefit
her clients. Her proximity to FDA also
facilitates planning for client FDA meetings
(e.g., recommended hotels and restaurants).
Hecker & Associates resources include
partners in Europe, the UK, Canada, and
Australia who can expertly guide clients through
biopharmaceutical regulatory and/or writing
processes in those regions, while Hecker &
Associates maintains current, “real world”
information to file appropriate regulatory
submissions to FDA to ensure the fastest and
best possible regulatory response.
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Food and Drug Administration
http://www.fda.gov/
US Government Printing Office
(GPO), Code of Federal Regulations
(CFR)
www.ecfr.gov
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The International
Conference on Harmonisation of
Technical Requirements for
Registration of Pharmaceuticals for
Human Use (ICH)
www.ich.org
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