Core Services
Ensure Validation. Eliminate Risk.
We offer a complete line of services to ensure client projects speed-to-market and success. Our experienced staff is by your side – from start to finish.
Pd
Project Delivery
We communicate and establish all appropriate project deliverables and processes up front to deliver the most effective, compliant outcome. Reach a qualified and validated state, with ValSource as your guide.
- Computerized System Validation
- Program Management
- Process Engineering
- Procurement/Expediting
- Construction Safety
- HAZOP
- Leed Certification
- Calibrations / Metrology
- Commissioning, Qualification and Validation (CQV)
Mi
Microbiology
ValSource microbiology consultants are experts in airflow visualization, aseptic processing, contamination control, deviation investigations, environmental monitoring, facility cleaning & disinfection, inspection readiness, quality assurance/control, risk analysis, and product safety. Their scientific knowledge, practical experience and regulatory awareness make them an essential part of issue resolution.
With unmatched experience in the life sciences industry, our team of microbiology consultants can provide valuable insights and solutions for a variety of needs. Trust ValSource to provide the expertise you need for your next project.
- Contamination Control
- Environmental Monitoring
- Process Optimization
- Quality Assurance and Compliance
- Risk Assessment and Mitigation
- Training and Education
- Troubleshooting and Root Cause Analysis
Co
Specialty Consulting
Expert advice when you need it most. ValSource is available to help solve the complex issues surrounding regulatory expectations for control strategies and assist with regulatory communications beginning with initial developmental stages through commercialization.
ValSource consultants have unparalleled expertise to help navigate the complex regulatory environment of emerging therapeutics and delivery systems. We provide full services for key challenges including employing a science driven, risk-based approach to ensure success. Our consultants are widely known as thought leaders on ATMP and transdermal product development and manufacturing.
- Microneedle & Transdermal Delivery Product Development and Regulatory Support
- GMP Consulting for Advanced Therapy & Medicinal Products (ATMPS)
- Process Engineering
Cv
Commissioning, Qualification & Validation (CQV)
ValSource technical teams, located in strategic locations across North America, provide experienced resources to assist clients in the planning, management, execution, and analysis of commissioning, qualification, and validation projects – in a safe, consistent, compliant, and timely manner.
- Capital Project Support and Staff Augmentation
- Project Planning: Scheduling, Budgeting, Reporting
- Project Management
- Commissioning, Qualification & Validation (CQV) Master Planning
- Requalification Strategy, Planning and Execution
- Design Review and Qualification
- FAT/SAT Planning and Execution
- Commissioning and Decomissioning Generation and Execution
- IQ/OQ/PQ Generation and Execution
- Facility, Equipment, and Utility Qualification
- Lab Equipment Validation
- Sterilization (SIP) & VHP Validation
- Cycle Development Container Closure Validation
- Computer System Assurance (CSA)
- Computer System Validation (CSV)
- Data Integrity Assessments
- Controlled Temperature Unit Mapping
- Airflow Visualization Studies
- Autoclave Cycle Development and Qualification
- Shipping Validation
- Proficient with Multiple Paperless Validation Platforms
- Technical Writer(s) for Validation, Manufacturing, Engineering and Facilities
Ms
Manufacturing Science and Technology (MSAT)
Our comprehensive suite of technical and scientific services are designed to streamline your operations and empower your business for success. With expertise spanning a wide array of disciplines, our consultants are equipped to tackle any challenge and have a proven track record of delivering innovative solutions and unparalleled support. Let us help you solve your challenges and drive your business forward with optimized performance and reliability.
- Technology Transfer
- Process and Operational Control Strategies
- Process Characterization and Optimization
- Operational Strategy
- Capacity Planning
- Failure Investigations, Root Cause Analysis, and CAPA
- Process Efficiency Improvement
- Process Transfer Expertise and Mentoring
- Fast Track/Light Speed Project Realization
- Sampling Plan Optimization and Development
- Cleaning Process Development and Validation
- Shipping Validation
- Process Change Management and Comparability Studies
- Process Commercialization and Lifecycle Management
- PPQ
- CPV
- CMC
Rm
Quality Risk Management (QRM)
Quality Risk Management (QRM) has evolved to be the cornerstone of all activities in product, process, and facility design, development, qualification, and operation. Our QRM team is comprised of best-in-class consultants who can develop novel approaches and fit-for-purpose strategies to comply with ICH Q9 (R1) and all of the associated regulations that require the use of QRM and risk-based decision making. Our approaches help your organization drive efficiency and appropriate resource utilization, reducing costs and improving product quality.
- Benchmarking/Maturity Assessments/Auditing
- QRM Program Development
- Training
- Facilitation
- QRM Master Plan Development and Implementation
- Tools and Templates (Standard and Customized)
- QRM Lifecycle Management and Risk Review
Mc
Metrology & Calibration
ValSource is ISO 9001 Certified for Calibration and Calibration Related Consulting Services for Pharmaceutical, Biotechnology, Medical Device, and Other Tech Companies. ISO 9001 Certification ensures our defined process and procedures are high quality, effective and consistently meet client expectations. We also provide instrument validation, including calibration with instant certificate access through PIMSHQ’s innovative PIMS software.
- Temperature Measure
- Speed
- Mass
- Pressure
- Pipettes
- Temperature Source
- Gases
Ss
Safety Solutions
Proactive planning matters. ValSource Safety Solutions can swiftly plan, direct, and implement a proper safety program to ensure a safe, healthy, and accident-free project and work environment. We are skilled in corporate safety and risk management, guaranteeing compliance with all applicable federal, state, county and local safety-related regulations. With PIMSHQ’s innovative software, we also provide you with access to documentation and critical areas needing attention from a safety perspective on-site.
- Site Specific Safety Plan (SSSP)
- Audit
- Risk Management
- Compliance
Rc
Regulatory Compliance
Our regulatory compliance strategy & support consulting services include:
- Inspection Preparedness
- Inspection Responses
- System Assessments, Aseptic Set-up, Sterile Fill-finish, Aseptic Processing Behavior
- Drug Substance and Drug Product Pre-license and Post-approval Changes and Manufacturing Preparedness
- Marketing Submission Strategy
- Pre-marketing Submissions (e.g., EUA’s, INDs, IDEs)
- Marketing Authorization Application Development
- Post-marketing Change Management, Validation Approaches, and Submissions
- Assistance with Regulatory Correspondence (e.g., Deviations, Regulatory Deficiency Responses, Post-inspection Communications)
- Product Validation Approaches
Lt
Learning & Training
As processes and systems become more complicated, having a workforce that can perform and respond appropriately when problems arise is essential. That means not only knowing the how-to, but also the what and the why. Risk-based-, quality-, and critical-thinking skills are more important today than ever before. ValSource Learning Solutions understands this and has a comprehensive set of innovative solutions to help your organization reach its goals.
ValSource Learning Solutions provides high-quality, customized courses including:
- Aseptic Technique Training and Coaching
- Gowning Training and Coaching
- Inspection Readiness
- Root Cause Investigations / CAPA
- Quality Risk Management (QRM)
- QRM Facilitator Training
- Basic and Advanced GMP Training
- Custom E-Learning Solutions