ABOUT US
OUR
FOUNDER
Quality Regulatory
Compliance LLC (QRC) was founded in April 2006 by Richard Aleman,
President. Richard Aleman
has 28 years of experience with the U.S.
Food and Drug Administration (FDA), both at the
FDA headquarters level and in the Office of
Regulatory Affairs, as part of the field
organization. International experience and
consultancies include assignments with the World
Health Organization and the Food and
Agricultural Organization of the United Nations,
as well as an FDA representative/presenter at international conferences in
El Salvador, Venezuela, Guatemala, Philippine
Islands, Canada, Argentina, Brazil, Mexico, and
the Commonwealth of the Northern Marina Islands.
In August, 2000, Richard Aleman successfully
made the transition from government service to
the regulated industry, where his career
focused on small to mid-size pharmaceutical
companies. He served in the position
of Director of Compliance during this time, and
his responsibilities included aspects dealing
with quality assurance, quality control and
regulatory affairs. Additional responsibilities
included establishing and managing both the
internal and external audit programs.
International experience included conducting
Active Pharmaceutical Ingredients (API) audits
in Switzerland and India.
ASSOCIATES
The experience level of QRC and associates spans
all FDA program areas, including, but not
limited to: foods, drugs, cosmetics, medical
devices, biologics, veterinary products,
bio-research, as well as, import/export,
and international operations. QRC, through it’s
president, Richard Aleman and associates, brings
to our clients the experience, integrity,
credibility, and confidence level necessary to
assure your company will be in total compliance
with the laws, regulations, and policy &
procedures administered by the FDA.
We take our clients Beyond
Compliance |