All newly accepted “Projects” between QV360 and the end-clients’ (Source Clients’), will receive a very competitive “Bill Rate” to make it worth your while.

Discover Global Excellence in Quality Engineering, Management, and Validation Consultation Services

Leading Expertise in Regulated Industries

At QV360, we are proud to offer comprehensive quality engineering, management, and validation consultation services. Since our inception in 2011, we have been dedicated to delivering superior consultation across a diverse range of services, including computer systems validation, information technology, digital validation, as well as equipment validation, process validation, and cleaning validation. Our wide-reaching expertise covers and abides by industry-specific regulations that would prepare you for cGMP inspection readiness, approval of new biological-derived products, drug, medical devices, cell/gene therapies in alignment with the regulatory laws and standards imposed by the FDA, EMA, KFDA, CFDA, WHO, and other global entities.

Comprehensive Consultation Services Offered

Digital, Computerized System/Information Technology Validation
Specializing in Computerized Systems/Information Technology Systems within GxP (GMP, GCP,GLP, and GDP) Manufacturing and Laboratory Environments
Quality Management and Assurance
Focused on GxP Quality Systems, Assurance, Engineering, and Operations
Commissioning, Qualifications, and Validation
Expertise in GxP Design, Equipment, Process, and Cleaning Validations

Worldwide Service Delivery

Operating from the United States and extending our services globally, from Europe to Asia, QV360 acknowledges no geographical limits. From Boston to California, our network of senior-level consultants—each seasoned with at least 20 years of experience in fields like pharmaceuticals, medical devices, and biotechnologies—ensures compliance and efficiency for all your validation needs, no matter where your operations lie.

Comprehensive Validation and Compliance Solutions

  • Advanced Technologies and Methodologies
    QV360 remains at the forefront of technological validation, including AI software validation and electronic quality management systems. Our methods are aligned with the latest industry standards, such as ASTM-E2500, GAMP 5 Edition 2, and Agile Methodologies, ensuring robust compliance and quality assurance across all project phases.
  • Diverse Industry Applications
    Our services are tailored to meet the stringent requirements of several key industries:
    Biopharmaceuticals, Medical Devices, and Vaccines: We provide everything from commissioning qualification validation (CQV) to post-execution batch reviews.
    Food and Beverages: Expertise in compliance and safety standards ensures the highest quality in consumer products.
    Cell and Gene Therapies: Our consultants are adept at navigating the complex validations required in cutting-edge therapy treatments.
  • Strategic Quality Management
    At QV360, we believe in a proactive approach to quality management, ensuring that potential discrepancies are addressed before they escalate into costly regulatory or compliance issues. Quality assurance, remediation, and risk management are framed within science-based strategies and regulatory insights, providing our clients with the confidence that all aspects of their operations exceed market expectations.
  • Affordability Without Compromise
    We understand that cost-efficiency is crucial to our clients. QV360 is committed to providing the most reliable support at competitive fees, ensuring that our quality-driven solutions are accessible to projects of all sizes without compromising on excellence.

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Exceptional Value with Competitive Pricing

We are committed to providing unparalleled value to our clients. Every project we undertake is bound by our promise of competitive billing rates, guaranteeing costs lower than any other quality-oriented consultancy offering equivalent services.
Our dedication goes beyond affordability; we ensure that the quality of work adheres strictly to GxP standards, catering to a wide array of industries, including pharmaceuticals, biopharmaceuticals, medical devices, vaccines, cell/gene therapies, biotechnologies, and the food and beverage sector. This commitment affirms our dedication to delivering high-quality outputs without compromising our service promise, ensuring that our clients receive the best possible value for their investment.

Pioneering Future Technologies and Education in Life Sciences Industries

  • QV360 meets and exceeds current and realistically envisions the future of computerized systems, information technologies, validation engineering, and quality assurance projected trends within the pharmaceutical, biopharmaceutical, cell/gene therapies, vaccines, and medical devices industries.
  • With the intent to educate and train the readers and stakeholders within the industry, QV360 publishes (Authors) over 150 cumulative articles (A high percentage of publications are peer-reviewed by highly qualified reviewing staff/boards or committees) while authoring various chapters within various Parenteral Drug Association (PDA) publishing books that have been thoroughly peer-reviewed and are highly known to be reputable for their scientific community accomplishments since 1946.
  • Numerous clients have told QV360 that the provided consultants, including the founder of QV360, have exceeded expectations, leading to many subsequent project extensions beyond the initial agreement by remaining active on projects within the allowable budgets as opposed to other consultants not being project extended.

Choose QV360 for Guaranteed Satisfaction

With close to 15 years of proven excellence and a global footprint, QV360 is your premier partner for all aspects of quality assurance and validation. Trust us to bring superior, “out-of-the-box” consultancy solutions that not only meet but exceed your expectations. Let us help you navigate the complexities of regulatory compliance with ease and expertise.
Count on QV360—where quality meets innovation.