Scientific Expertise

  GLP Compliance

  Report Writing

  IND/NDA Documentation 

  Additional Resources

  Company Profile 

  Contact Us

 

 

World-Wide Consultants in

Toxicology and Regulatory Affairs

 

Argus International, Inc.

Argus International, Inc.
933 Horsham Road, Horsham, PA 19044 USA
TEL:  215-672-8867     FAX:  215-672-3619
www.argusinternational.org 
mbvargo@comcast.net

 

 

Argus International, Inc.

 
 
Consulting services for industry, regulatory agencies, law firms and professional organizations in the United States, Europe and Japan on:
  •   General Toxicology
  •   Neurotoxicology
  •   Reproductive Toxicology
  •   Photobiology
  •   Risk Assessment
  •   Behavioral/Functional Teratology  
  •   Developmental (Embryo-Fetal Toxicity/Teratogenicity) Toxicology
  • Audits of reports, tables and raw data
  • Critical phase and facility inspections
  • Simulated agency inspections (FDA, EPA, OECD)
  • Standard Operating Procedure audits
  • Quality assurance unit procedure and record keeping          inspections/audits
  • Automated data collection systems inspections/audits
  • Train quality assurance unit personnel
  • Establish, update and historically track Standard Operating Procedures
  • Review protocols
  • Establish critical phase inspection schedules
  • Conduct GLP seminars
  • Establish and maintain archival procedures
  • Conduct training seminars on agency inspections, Standard Operating  Procedure writing and tracking, and inspection/audit procedures
  • Validate automated data collection programs and equipment
  • Validate 21CFR Part 11 compliance

     Back To Top

 
 
  • Position Papers
  • Expert Opinion
               -  Court Litigations
               -   Agency Hearings
               -   Expert Panel Discussions
  • Regulatory Submissions (US, Europe and Japan)
  • Critical Reviews of Reports
  • Data Tabulation and Statistical Analysis
  • Literature Searches and Reviews
  • Protocol Development and Audit
  • Evaluation of Dosage Range Studies
  • Placement and Monitoring of Preclinical and Clinical Studies
 
 
  • Data Analysis and Preparation of Tables and Reports to GLP standards
  • Generation of Journal Manuscripts from existing studies for  publication in the  United States or Internationally
  • Preparation of Abstracts and Poster Sessions

 Back To Top

PREPARATION OF

IND AND NDA DOCUMENTATION

 

  Provided by AI Consultants

  Required Contents of the IND

  NDA Additions

  Services Provided

  • Experienced in preparing INDs and NDAs for submission
  • Record of approval
  • Ability to manage/prepare complete IND or any specific part
     
  • Form 1571
  • Table of Contents
  • Introductory Statement
  • General Investigational Plan
  • Investigator’s Brochure
  • Protocol(s)
  • Chemistry, Manufacturing and Controls Data
  • Pharmacology and Toxicology Data
  • Summary of Previous Human Experience
  • Additional Information

NDA Additions

  • Chronic toxicity (6-month rodent; 1-year non-rodent)
  • Carcinogenicity (2-year rat and mouse)
  • Reproductive toxicology
  • Additional PK (ADME)
 
 
  • Secrecy agreement
  • Review existing documents for GLP compliance; and determine and address deficiencies
  • Interact with FDA regarding timing and presentation of pre-IND meetings and all other required activities
  • Design, conduct and/or monitor in vitro and in vivo nonclinical studies for scientific and/or GLP compliance
  • Assemble data, prepare IND and/or NDA, including Investigator’s Brochure
  • Contract and monitor clinical trials
  • Submit IND/NDA

  ADDITIONAL RESOURCES

 
  • Network of Consulting Scientists and Auditors
  • Historical Control Data as tabulated by Argus Research Laboratories, Inc., for CD rats and NZW rabbits
  • Validated computer programs for  Statistical Analyses
  • On line communications

COMPANY PROFILE

 HISTORY

 CORPORATE EXPERIENCE

  REGISTRY OF EXPERTS AND ORGANIZING EXPERT PANELS

 DOCUMENT PREPARATION AND PUBLICATION EXPERIENCE

 QUALITY ASSURANCE

 CORPORATE FACILITIES AND EQUIPMENT

 

HISTORY 

Since Argus 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.

Argus International 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. 

 

CORPORATE EXPERIENCE  

Argus International 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 publication.

Project Management.  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 effort.

Expert Reports, Reviews, and TestimonyConsulting 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

Argus International 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.

 

DOCUMENT PREPARATION AND PUBLICATION EXPERIENCE

Desktop Publication.  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.).

Reports and Data TabulationData from studies conducted at other facilities are frequently sent to Argus International for analysis and interpretation.  Additional tabulation and statistics can be performed.

Manuscript PreparationScientists 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.

Journal Publication.  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).

Course Materials.  Argus International has extensive experience in the preparation and distribution of course materials (presentations, workbooks, course notes etc.).

 

QUALITY ASSURANCE

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.

Argus International 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 related topics.

Argus International 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.

 

CORPORATE FACILITIES AND EQUIPMENT

Location.  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.

Computer and Communications Equipment.  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. 

Back To Top

CONTACT US

Marjorie Vargo
Business Development

                Argus International, Inc.

                933 Horsham Road

                Horsham, PA 19044

                Tel:  215-672-8867                 Fax:  215-672-3619

                 Email:  mbvargo@comcast.net