of Consulting Scientists and Auditors
•Historical Control Data as
tabulated by Argus Research Laboratories, Inc., for CD rats and NZW
•Validated computer programs for
•On line communications
OF EXPERTS AND ORGANIZING EXPERT PANELS
PREPARATION AND PUBLICATION EXPERIENCE
FACILITIES AND EQUIPMENT
International was founded in 1980 by Dr. Mildred Christian, the
organization has provided scientific project management and other expertise to
companies, organizations and agencies in the U.S., Europe and Japan. International Regulatory Groups [the European Community (EC), the
Organization for Economic and Cooperative Development (OECD), the Japanese
Ministry of Health and Welfare (JMHW) and the Australian Ministry of
Health and Welfare (AMHW)], sectors of the FDA, EPA, the State of
California and multiple organizations in the private sector have made use of our consulting and/or support services. For any
given assignment or project, may draw upon an established
network of many prominent specialists who are experts in their fields.
Dr. Alan Hoberman is president of Argus International. He is assisted by Marjorie Vargo, who has served as coordinator and daily business manager since 1989.
provides extensive consulting services for long-term and short-term
projects in project management, information management (collection and
disbursement) and personnel management (organization and the conduct of
expert meetings and panels). We have substantial
experience in providing these services that require overall management of
specific activities and/or site selection. Other commonly requested
services we provide are preparation of scientific
reviews and position papers, quality assurance audits of various types,
re-calculation and re-tabulation of data for studies conducted by private
laboratories, provision of expert opinions (panel, agency or court),
preparation of INDs and NDAs.
provides exceptional capabilities in discerning potential risk to human
reproduction. Argus International has conducted numerous evaluations of
the potential of chemicals and chemical mixtures, as well as
pharmaceuticals, to adversely impact human development and reproductive
capacity. Dr. Christian and other scientists associated with Argus
International have served extensively on expert panels and review
committees in the US and around the world. In addition, Argus
International has experience and expertise in project management, quality
assurance, expert panels, symposia, development of INDs
and NDAs, literature search and reviews and manuscript preparation and
Companies whose own resources may be stretched, who have limited
experience and expertise in specific areas, or may be from a company
outside the U.S., frequently call on Argus International to manage major
projects like IND or NDA submissions. Argus International can manage the
communications, monitoring, study/laboratory selection, required personnel
and paperwork on an "as needed" basis saving the company time, money and
Reports, Reviews, and Testimony.
Consulting scientists have provided extensive reports, reviews and
testimony on human and environmental risk assessment for clients (US,
Europe, Japan, China and Australia) in private industry, government
agencies, legal firms and expert panels on a wide range of subjects
including chemicals, pesticides, drugs and pharmaceuticals, water and
potentially toxic substances.
REGISTRY OF EXPERTS
maintains a large registry of experts with various specialties. A working
relationship for this network is maintained through many means of contact
including: working on specific projects; membership in professional
organizations and societies; participation in symposia, workshops and
committees and contact with key personnel in industry, academia and the
agencies. An impressive number of scientists with experience and
expertise in various areas of toxicology (especially
reproductive developmental and most recently juvenile) and risk assessment are currently under
Confidentiality Agreement with Argus International. The staff at Argus
International has successfully planned and presented numerous symposia,
expert panels and other meetings on a wide range of topics.
PREPARATION AND PUBLICATION EXPERIENCE
Argus International has extensive in-house desk-top capabilities including
experienced staff, appropriate software and necessary computers and
printers to produce any type of document (electronic, hard copy, manuscripts, programs, instruction manuals, course books, posters, etc.).
Data from studies conducted at other facilities are frequently sent to
Argus International for analysis and interpretation. Additional
tabulation and statistics can be performed.
Scientists associated with Argus International are extensively published authors in the United States and internationally in a variety of peer-reviewed journals, text books and reference books. We have provided editorial assistance in the preparation of individual chapters and entire books.
Argus International has prepared manuscripts for publication for major pharmaceutical companies and associations including Wyeth-Ayerst, Robert Wood Johnson Pharmaceutical Research Institute, the Soaps and Detergents Association and the Chemical Manufacturers Association, BASF, ILSI, Creagri and RIFM.
During the 10 years that Dr. Christian served as Editor-in-Chief of the
Journal of the American College of Toxicology, the staff of Argus
International solicited and prepared manuscripts, handled the peer review
process, and provided the documents to the Journal publisher meeting
publication deadlines for six volumes per year.
Currently the staff is providing the same management and support services for Dr. Alan Hoberman, Editor-in-Chief of Toxicology and Industrial Health (Sage Publishers).
International has extensive experience in the preparation and distribution
of course materials (presentations, workbooks, course notes etc.).
Argus International can
provide GLP compliance consulting services in two major areas, audit/
inspection services and quality assurance unit services. Inspection/audit
services include: audits of reports, tables and raw data, critical phase
and facility inspections, simulated agency inspections (FDA, EPA, OECD),
standard operating procedure audits (including corrections and maintenance),
quality assurance unit procedure and record keeping inspection/audits and
automated data collection systems inspections/audits. Quality assurance
unit services include: training, establishment, update and tracking of SOPs,
review of protocols, establishment of critical phase inspection schedules,
conduct of GLP seminars, establishment and maintenance of archival
procedures, conduct of training seminars on agency inspections, SOP writing
and tracking, and inspection/audit procedures.
managed the complete overhaul and establishment of SOPs for a pharmaceutical
company to bring it up to GLP standards. Argus International consultants
worked with company scientists and personnel to revise and supplement their
skeleton set of SOPs so that GLP standards could be met. Argus
International auditors are frequently employed on a "by-project" or on-going
basis to conduct in-house audits of raw data, reports, tables, etc.
Extensive audits of studies, tables and data may also be conducted at the
Argus International office in connection with the preparation of INDs and
NDAs. Argus International has also provided extensive training on GLPs,
regulatory affairs, Quality Assurance as a standard of excellence and other
maintains an extensive registry of experienced auditors and reviewers who
can provide any Quality Assurance service required. Additionally, as
Executive Director of Science and Compliance of Charles River Laboratories
Discovery and Development Division, Dr. Christian has current information on
any regulatory changes that may occur in U.S. and international guidelines.
Argus International is located in a fully modernized historic registered
farmhouse within the Babylon Industrial Park in Horsham, PA, a suburb of
Philadelphia and is approximately 45 minutes from the Philadelphia airport
via expressway and five miles from the Pennsylvania Turnpike. Office space
that can be dedicated to the needs of a particular
client is currently available within this facility.
Argus International offices are equipped with state-of-the-art computer
equipment and software. High speed Hewlett Packard and Xerox laser printers
and ink jet color printers are used to produce hard copy. All computers and
PC's are equipped with Windows® operating systems and software.
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Argus International, Inc.
933 Horsham Road
Horsham, PA 19044
Email: [email protected]