Customer Profiles

Pharmaceutical and Biotech

    Of all drug candidates selected for development in the pharmaceutical industry, few make it to clinical trials. Fewer still go on to become successful and profitable products. With the odds stacked against them, pharmaceutical companies are now defining their business objectives to maximize their probability of success. In short, they must innovate faster, reduce risk, and increase profitability Companies in the life sciences industry are under intense pressure to increase productivity and make research and development (R&D) more efficient. Companies face discovery and development cycles that often total 7 to 10 years, as well as development costs approaching US$800 million for each new drug. What’s more, costs are outpacing revenue from new products. In the last 10 years, pharmaceutical spending on R&D has gone up 44 percent, but the number of blockbuster product launches has decreased by 25 percent.

    To ensure public health, federal regulations require all manufacturers to maintain secure and auditable trails of information pertaining to every phase of the development and manufacturing process. Built into the Oracle E-Business Suite is a framework that complies with the FDA’s 21 CFR Part 11 and cGMP regulations governing electronic records and e-signatures.

Customer Profile  This customer develops pharmaceutical products based on advanced (inhalable and injectable) time release drug delivery systems. They have developed delivery systems for drugs that address medical disorders including schizophrenia, alcoholism, growth disorders, and diabetes. For this Multi-Site Pharmaceutical Manufacturer the Implementation and Upgrade activity took place in a fully validated environment and included:
  • Upgrade of Corporate Facility from older release of Oracle Financials and OPM, and documentation for Sarbannes-Oxley compliance audit.
  • New implementation of Oracle OPM at the main Manufacturing Facility
Reilly & Associates provided the business scripts as input for Operational Qualification (OQ)



Customer Profile  This customers mission is to enhance and extend lives through the development of superior health care products for a wide range of cancers, infectious diseases and autoimmune disorders. Their products include investigational personalized cancer vaccines and one of the worlds most widely studied immune adjuvants.
    R&A implemented Oracle Process Manufacturing and assisted with the FDA validation of the Oracle System.

Customer Profile  This customer is a biopharmaceutical company that discovers, develops, and intends to commercialize medicines for the treatment of serious medical conditions. They have product candidates in clinical trials for the potential treatment of cancer, rheumatoid arthritis, and eye disease. The Company is also a contract producer of commercial drug substances. R&A implemented Oracle 11.5.9 with full FDA validation and Sarbannes-Oxley audit. Oracle Financials was already in place prior to the Process Manufacturing project. Some streamlining of the current Oracle Purchasing was done to facilitate the OPM installation.

Customer Profile  This customer is a research-based pharmaceutical company dedicated to treating and preventing human disease. Their drug development program has yielded an extensive portfolio of pharmaceutical compound candidates. Reilly & Associates was selected do to:
  • Extensive experience in FDA validation in the OPM Environment
  • Reilly & Associates comprehensive set of Validation Test Scripts
  • 114 OPM Unit Test Scripts combined with business scenarios and process flows for system validation.
  • These scripts are modified and augmented to support the implementation and create company specific Standard Operating Procedures in a GMP and Part 11 compliant environment.
  • Assistance meeting requirements for Operational Qualification (OQ), Installation Qualification (IQ) and Performance Qualification (PQ). Sepracor was attracted by R&A’s ability to supply scripts and templates for the OQ, and OPM knowledge for the creation of the Validation Master Plan, User Requirements, and Functional Specifications. In addition, R&A have been able to provide guidance in the design of the Performance Qualification.

Customer Profile  A world-leading, innovation-driven animal health company, providing a comprehensive range of products to enhance the health, well-being and performance of a wide range of animals. This customer employs approximately 6,000 people and operates in more than 150 countries worldwide. Its sales are in excess of $1.8 billion.
    Reilly & Associates partnered with a large high profile consulting firm in this implementation. Reilly & Associates was responsible for the Oracle Process Manufacturing portion, and assisted with the validation initiative. This validation initiative was particularly complex with the requirement to meet both FDA and USDA validation requirements for live and killed (organism) vaccines.

Customer Profile  This customer is a diversified biotechnology company with over $410 million in revenues. They discover, develop, and sells biocatalysts and other biochemicals for the industrial, consumer and agri-processing markets. They have drug development platforms in targeted bio-therapeutics for cancer. This is a Multi Site International Pharmaceutical Manufacturer. The implementation project addressed the upgrade from GEMMS to Oracle OPM 11i. Reilly & Associates provided project management, OPM, Purchasing, Financials and DBA assistance.

Customer Profile  This customer is a world leader in the development and production of antibodies and instruments for the diagnostic industry. Specializing in the fields of immunocytochemistry, flow Cytometry, Clinical Immunochemistry, and Microbiology with 1300 employees worldwide.
The Client had previously implemented the Financials and OPM in their operations in Europe. Reilly was selected by to implement Oracle Discrete Manufacturing at its Rocky Mountain Instrument manufacturing plant and to implement OPM at its West Coast antibodies production facility.

Customer Profile  A leading companion animal health company with products in the pharmaceutical, dermatological and oral hygiene markets for pets. The company’s commitment to the industry has brought forth new innovations and discoveries in dermatology, oral hygiene, insect control, nutraceuticals/pain management and canine heartworm prevention. They pioneered the use of hypoallergenic shampoos, colloidal oatmeal shampoos and conditioners, leave-on lotions, patented technology to increase efficacy and prolong activity, and many other great ideas and products. Reilly & Associates implemented the full OPM suite at this client.

Customer Profile  A privately owned pharmaceutical company that develops and markets generic prescription drugs focused on antiviral medications used in the treatment of Hepatitis C.

Implementation activity included:
  • General Ledger
  • Accounts Payable
  • Accounts Receivable
  • Order Management
  • Purchasing
  • Oracle Process Manufacturing