Experienced life science professionals and subject matter experts (SME) for the engineering, scientific, manufacturing, technical, and quality areas for the industry. Specialized but not limited to Pharmaceutical, Bio-Pharm, Medical Devices and Drinking Water industries. We supply services and/or resources on the Science and Technology fields. Passionate leaders with extensive experience in Development, Manufacturing (API, BioPharma and Sterile filling), Solid Dosage, and Devices: executing, leading / directing - Product Design, Research & Development, Technical Transfer, Project Management, Validation, Manufacturing, Quality Systems, Strategy, Product Development Management (from Development to Product Commercialization) and People Development. Vast knowledge on regulations CFR’s, 21 CFR 210/211 & 820 and ISO Standards 13485, 13408, 14644, 9001, 11137.

1. Solutions in the Science and Technology Field
911 Washington Ave.
Suite 710
St Louis MO 63101
www.Sytech-IS.com

2. Engineering, Innovation and Scientific Consulting Firm
Experienced life science professionals and subject matter experts (SME) for the
engineering, scientific, manufacturing, technical, and quality areas for the industry.
Specialized but not limited to Pharmaceutical, Bio-Pharm, Medical Devices and
Drinking Water industries. We supply services and/or resources on the Science and
Technology fields.
Passionate leaders with extensive experience in Development, Manufacturing (API,
BioPharma and Sterile filling), Solid Dosage, and Devices: executing, leading / directing
- Product Design, Research & Development, Technical Transfer, Project Management,
Validation, Manufacturing, Quality Systems, Strategy, Product Development
Management (from Development to Product Commercialization) and People
Development. Vast knowledge on regulations CFR’s, 21 CFR 210/211 & 820 and ISO
Standards 13485, 13408, 14644, 9001, 11137.

3. Resources and Services Areas
Engineering Consulting
• Prototypes Design and Manufacturing/
Partnership
• Process Engineering Support
• Mechanical Engineering
• Chemical Engineering
• Project Management
• Equipment selection and optimizations
• Feasibilities
• Filtration and Isolation
• FMEA’s
• Plant, Contract Manufacturer Assessments and
Operations
• Aseptic Areas
• Factory Acceptances Test (FAT) and Site
Acceptances Test (SAT)
• SAP
Scientific Consulting
• Research and Development Support
• Process Development
• Analytical Development
• Cleaning Assessments and Site programs
• Feasibilities
• Technical Transfers
• Process Optimization
• Designs of Experiments (DoE)
• Process Analytical Technologies (PAT)
• Statistical Process Specifications and Controls
• Laboratory Controls and Data Integrity
• Aseptic Processing
• Microbiology
• Organic Synthesis and Molecules
Characterizations

4. Services Areas
Good Manufacturing Practices GMP’s
and Good Laboratory Practices GLP’s
• Support client’s compliance with Code of
Federal Regulation (CFR’s), 21 CFR 210/211
& 820 and ISO Standards 13485, 13408,
9001, 11137
• Audits
• Our company provides Assessment and
Recommendations for the following;
Regulatory Compliance
Quality Control / Quality Assurance
Validation Master Plan
Products and Processes Investigations
Corrective Actions and Preventive
Actions (CAPA)
Laboratory Management
Validation
• User requirements Specifications
• Validation Master Plan
• Building and Utilities
Qualifications/Commissioning's
• Equipment Installation, Operational Qualifications
and Performance Qualifications
• Computer System Validation
• Process Validation
• Cleaning Validation
• Re-qualifications
• Sterile Filling
• Packaging Lines
• Sterilization Co60