Compliance Scientific, LLLP
Providing Specialized Contract Validation Services to Pharmaceutical Manufacturers
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Validation Services
 Validation/cGMP services
 Master project plan generation
 Protocol generation
 Protocol execution

 

 

Document Preparation
  Cleaning validation
 Equipment qualification validation
 Computer systems validation
 Process validation
Services Overview
We are eager to serve you! Compliance Scientific, LLP (CS-LLLP) is a validation services contracting and consulting company.  We have performed validation services throughout the United States and Canada, to FDA regulated industries (Pharmaceutical, BioPharmaceutical, and Ophthalmic Solutions).  We focus on providing personnel to compliment your existing resources. We offer services for validating manufacturing systems and processes.
Compliance Scientific generates validation documents to meet clients’ requirements.  Our technical and project experience makes us uniquely qualified to perform any project.
Document Preparation
 Validation master project plans
 Cleaning master plans
 IQ/OQ/PQ protocols and summary reports
 Standard procedures for operating, cleaning, and maintenance
Field Testing
 Cleaning verification
 Cleaning validation
 Computer systems
 IQ/OQ/PQ testing of process and utility systems
Validation Services
Compliance Scientific provides specialized validation services.  This consists of document preparation, field execution, and summary report generation.
Bob Gordon (owner of Compliance Scientific) has 21 years of experience in performing these services for equipment, utilities, computer systems, and processes in the Pharmaceutical (API), Biotechnology, and Ophthalmic Solution Industries.
Company
Compliance Scientific is incorporated in the state of Colorado. Providing validation services throughout the United States, we are validating manufacturing systems, cleaning procedures, processes, and computer systems. These services are for clients that must adhere to current Good Manufacturing Practices (cGMPs).
Clients
We help our clients to achieve their validation goals and meet their target due dates. In addition, we work with your staff to create great teams! Over the last twentyone years, we have proudly served the following pharmaceutical companies:
Allergan, Inc.
Amgen, Inc.
ALK Abello Source Materials, Inc.
Atrix Laboratories, Inc.
Aventis Pasteur, Inc.
Baxter Corporation, Hyland Division
Bayer Corporation
Boehringer-Ingelheim, GmbH.
Computer Compliance, Inc.
DuPont Corporation
Emergent BioDefense Operations Lansing, Inc.
Genentech, Inc.
Hauser Technical Services, Inc.
La Jolla Pharmaceutical Company, Inc.
Massachusetts Biologic Laboratories
Michigan Biologic Products Institute
NaPro BioTherapeutics, Inc.
Novex Pharma, Inc.
Ortho Diagnostics, Inc.
Pfizer, Inc.
Paxis Pharmaceuticals, Inc.
ProPharma Group, Inc.
Protein Design Laboratories, Inc.
3M Pharmaceuticals, Inc.
Rocky Mountain Compliance Specialists, Inc.
Synergen, Inc.
The DiLisi Group, Inc.
Upjohn Corporation
Whitehall-Robins, Inc.
ZymoGenetics, Inc.
 
Document Preparation
 Risk/Failure mode and control analysis
 Design qualification
 Environmental monitoring protocols and final reports
 Process validation protocols, interim reports, and final reports
Field Testing
 Cycle development
 Requirements traceability
 Factory acceptance
 Environmental monitoring
Why Should You Consider Us?
We are providing specialized contract validation services and have twentyone years experience in facility, process, and computer systems validation to benefit you! Fourteen other companies in the last ten years have utilized our services and have achieved their goals and met their target due dates! We will help your staff be a hot team. 
Why You Should Order Our Services Today
During validation, we are providing solutions to quickly fix systems and get your manufacturing process back on-line. Sign our proposal today, and we will include a complimentary Steam-In-Place training session. We look forward to serving you!
Each year, $5,981,487,000 are spent developing and manufacturing pharmaceuticals in the US1. Moving pharmaceutical products more efficiently through development and regulatory processes reduces both direct and opportunity costs. Winners of  the race-through both natural and learned abilities--can expect to be rewarded for their speed. In the race to develop and commercialize pharmaceuticals, that reward is on a multibillion-dollar scale. 'Speed Demon' companies can both extend patent-protected product sales and create 18-24 months of time savings within which they can generate sales, enter markets early, grow those markets quickly, and invest in future R&D initiatives. Sales during that 18- to 24- month period frequently go unchallenged by competitors. Compressing drug development cycle times is a critical objective for senior management at AstraZeneca. A single day of delay carries significant direct and indirect costs2. For an average product, a single day of delay results in approximately $1.3 million in lost prescription sales. For new blockbusters, a day's delay may be 10 times that amount.  For example, each day of delay for developing Prilosec cost $11.2 Million US dollars3.
1 Source: PhRMA Pharmaceutical Industry Profile 2000. www.pharma.org, October 4, 2000.
2 Source: Speed Demons of Drug Development. ISSN: 0279-6570; Advanstar Communications, Inc, July 2000.
3 Source: CenterWatch, a clinical trials information company based in Boston.
Copyright© 2008 by Robert Gordon
Validation Services
 Summary report preparation
 Standard procedure (SOP) preparation
 Start-up and commissioning
 Cycle development
Training Services
 Steam-In-Place (SIP) training
 Cycle development training
 Commissioning
 Qualification