How Can We Help You?

When you partner with ValSource, you partner with leaders in risk management, process validation, and continued verification. We stand with you every step of the way.

ValSource Corporate Contact Information

  • 610.269.2808
  • 918A Horseshoe Pike,
    Downingtown, PA 19335
  • This field is for validation purposes and should be left unchanged.


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.

By harnessing our full complement of expertise and streamlined practices, ValSource enhances total project delivery. We pride ourselves on executing projects with precision and efficiency, which not only eliminates rework but also maximizes overall project efficiency. Our strong track record of successful delivery of capital projects demonstrates our commitment to excellence and delivering optimal results for our clients.

  • Computerized System Validation
  • Program Management
  • Process Engineering
  • Procurement/Expediting
  • Construction Safety
  • Leed Certification
  • Calibrations / Metrology
  • Commissioning, Qualification and Validation (CQV)


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


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



ValSource microbiology consultants are well-known for their scientific knowledge, regulatory awareness, and unmatched practical experience in the life sciences industry. Our team of experts are an essential part of proactive process development and issue resolution, providing valuable insights and solutions for a variety of project needs.

  • Airflow Visualization
  • Aseptic Processing Simulation
  • Environmental Monitoring
  • Contamination Control
  • Process Optimization
  • Quality Assurance and Compliance
  • System Assessments
  • Aseptic Set-up
  • Sterile fill-finish
  • Aseptic processing behavior
  • Risk Assessment and Mitigation
  • Training and Education
  • Troubleshooting, Root Cause Analysis and investigation support
  • Regulatory support
  • Cleanroom behavior


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


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


Regulatory Compliance & Support

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, 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)
  • Process Validation Approaches


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


Metrology & Calibration

ValSource is ISO 9001 Accredited for Calibration and Calibration Related Consulting Services for Pharmaceutical, Biotechnology, Medical Device, and Other Tech Companies. ISO 9001 Accreditation 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 software.

  • Temperature Capabilities
  • Speed
  • Mass
  • Pressure
  • PH/conductivity
  • Pipettes
  • Gases
  • Light
  • Staffing and consulting


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

Annex 1 revision experts.

Our consultants are highly-recognized for their Annex 1 knowledge and expertise. We provide a plan forward through Annex 1 updates, today and into the future.