A Company Like No Other

A Company Like No Other

Our Vision

Our Vision

how can we help you ?

Where We Excel

Meticulous, thorough, consistent

Meticulous, thorough, consistent

We provide solutions that unites compliance, quality systems and tools, validation, training structure, and document management. We enable companies to create and better meet ISO standards, and FDA regulations.

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Validation is in the Details

Validation is in the Details

We manage and execute your validation needs by creating plans and requirements that balance your business' needs. We bring your documentation to a level that ensures a state of control that meets regulatory and compliance requirements. ​

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Minimizing Audit Impact

Minimizing Audit Impact

We offer customized services that keep clients abreast of emerging and current laws and regulations. We provide our services on the federal, state, and local government levels.

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Top To Bottom Management

Top To Bottom Management

Complete solutions for teams to succeed in fast-paced environments. Analyze business requirements, identify deficiencies, and develop cost-effective solutions to enhance productivity, revenue and improve customer service.

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Translating Business Into Execution

Translating Business Into Execution

Clear, visual and objective documentation at every stage. Compliance with ISO and FDA regulations From Batch records to process flows!

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Closing the Loop with Top Tier IT Services

Closing the Loop with Top Tier IT Services

We provide cloud and web-based tools, apps, and software packages to fit your business. QuickBase, SharePoint, Analytical s/w and more!

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We are unique

Why Choose Us?

Professional Staff

Hand selected and vetted. We only hire top tier professionals.

Experience

We collaborate and innovate all over the world.

Flexibility

We are fortunate to have expertise in many areas and can help with all your business needs.

Rates

We offer fair and competitive rates. Quality and value are paramount to our success.

Why Choose Us?

Testimonials

Humbled by Client Satisfaction

I can't say enough about the level of professionalism and execution that AQS brought to the table. Within minutes we felt we were finally on the right path!

Eugene Long, Director Validation, PMV Group
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Some Helpful

Frequently Asked Questions

With interdisciplinary teams and extensive internal resources, AQS’s global regulatory affairs staff is flexible and responsive to your needs. Our regulatory consulting services include:
  • Clinical trial applications
  • Marketing applications
  • Medical devices
  • Medical writing
  • Publishing and submissions
  • Lifecycle management
  • Preclinical and CMC consulting
  • Agency interactions
  • Strategic consulting and intelligence
  • Quality review
So what is the difference between a PMA and a 510(k)? The approval process for PMA devices is similar to that for prescription drugs, meaning that the FDA requires the manufacturers of PMA devices to prove efficacy and safety by providing data showing the device’s performance in humans. The FDA also has the authority to regulate the promotion of PMA devices. As with prescription products, the manufacturers of PMA devices cannot make false or misleading claims about their devices; they also must include warnings and contraindications in any advertisement.
  1. Drug discovery and target validation
  2. Preclinical testing
  3. Investigational New Drug application filing
  4. Phase 1 clinical studies
  5. Phase 2 clinical studies
  6. Phase 3 clinical studies
  7. New Drug Application filing
  8. PDUFA date and decision
  9. Phase 4 clinical studies
  1. Manufacturing Process Validation (PV): Bio, Vaccines, Pharma, Med Devices, Consumer Products
  2. Packaging Process Validation (Pkg V)
  3. Cleaning Validation (CV)
    • i. Cleanability Studies
    • ii. Detergents Evaluation
    • iii. Sanitizing Agents Studies
    • iv. Recovery Studies
    • v. Microbial Load
    • vi. Active Drug Solubilities and Sampling
    • vii. Surfaces Areas and Sampling Points
    • viii. Holding Times (Prior and Post Cleaning Process)
    • ix. Worst Case Studies
    • x. Bracketing
    • xi. New Approaches to Cleaning Validation
  4. Analytical Methods Validation (MV)
  5. Analytical Methods Transfer
  6. Software Validation and CSV
  7. 21 CFR Part 11
  8. Network / IT Infrastructure Validation
  9. Risk Based C&Q, Cleaning and Process Validation
  10. Validation Master Plans
  11. Process Support / Monitoring
  12. Maintenance of Validated Status: Verification vs. Validation? We apply QRM most recent approaches
  13. Revalidation
  1. Green Building Commissioning
  2. Manufacturing and Packaging Equipment Qualification (IQ,OQ,PQ)
  3. Design Qualification (DQ)
  4. Maintenance System Qualification
  5. Utilities Qualification
  6. Facilities Qualification
  7. FAT / SAT
  8. Risk Assessment
  9. Risk Management: Direct vs. Non-Direct Impact; Critical Vs. Non-Critical
  10. Commissioning and Enhanced Commissioning
  11. Decommissioning
  12. Integrated Validation Approach
  13. Suppliers / Materials
  14. Personnel
  15. Instrumentation
  1. Interpretation and Application of Quality Risk Management Guidelines (ASTM, ISO)
  2. Leverage testing from Commissioning (Enhanced Commissioning)
  3. Eliminate redundant paperwork during qualification
  4. Reduce test cases based on risk assessments
  5. Interpretation and Application of new standards based on Risk Based Approach
  6. Streamline practices and procedures
  7. Develop risk management exercises (e.g., FMEA)
With highly-graphical materials that clearly and convey the scientific, technical, and operational aspects of your company/operations. Our approach at AQS is to transmit complex technical topics through an effective combination of highly-illustrative graphics and clear and precise language. AQS will address each stage of your operation: Batch Records, SOPs, Trainings, Knowledge Diagrams and Visual Aids, improving operations and compliance with Good Manufacturing Practices.
  1. Implementation of FDA cGMP/compliant quality system FDA Inspections
  2. FDA Pre-Approval Inspections (PAI)
  3. Mock Inspections and cGMP assessments
  4. Investigation and CAPA System
  5. Human Error Reduction and Prevention Programs
  6. Implementation and enhancement of Quality Risk Management programs
  7. Quality by Design and Pharmaceutical Development Support
  8. Annual Product Review/Product Quality Review Support and outsourcing, including data trending and analysis
  9. Computer System Validation and 21 CFR Part 11
  10. Data Integrity audit and Assessment, Remediation and Training
  11. Validation Life Cycle
  12. Operational Supplies
  1. Implementation of FDA cGMP/Compliant Quality System
  2. FDA Inspections
  3. FDA Pre-Approval Inspections for PMA
  4. Mock Inspections and QSR Assessments
  5. Investigation and CAPA System
  6. Human Error Reduction and Prevention Programs
  7. Implementation and enhancement of Risk Management programs
  8. Design Control
  9. Computer System Validation and 21 CFR Part 11
  10. Data Integrity audit and Assessments, Remediation and Training
  11. Validation Life Cycle
  12. Operational Support
  1. Implementation of FDA cGMP/Compliant Quality System FDA Inspections
  2. FDA Pre-Approval Inspections (PAI)
  3. Mock Inspections and cGMP/QSR Assessments
  4. Investigation and CAPA System
  5. Human Error Reduction and Prevention Programs
  6. Implementation and enhancement of Quality Risk Management programs
  7. Annual Product Review/Product Quality Review Support and Outsourcing, Including Data Trending and Analysis
  8. Computer System Validation and 21 CFR Part 11
  9. Data Integrity Audit and Assessment, Remediation and Training
  10. Validation Life Cycle
  11. Operational support
1. AQS before starting any project will ensure that 4 key components are clearly defined and understood for any project (gather requirements for all pillars from the executive teams):
  • Budget
  • Schedule
  • Staff
  • Goals
2. Though there are a whole host of skills, knowledge areas, methodologies, etc. to consider, AQS thinks being a successful PM comes down to your ability to do a few key things really, really well:
  • Communicate Effectively
  • Organize and Juggle
  • Solve Problems and Make Decisions
  • Build Good Teams
1. A project evaluation is about figures. The stories form part of it too, but a smaller part. During a project evaluation you look at:
  • Schedule
  • Quality
  • Cost
  • Stakeholder satisfaction
  • Performance to business case
2. AQS will consider a successful project when all goals are met for all project evaluation figures (these measures of success are quantified in the project charter)

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