Skip to Content
Merck
CN
HomeServicesProduct ServicesSingle-Use and Filter Validation ServicesValidation Service Levels

Validation Service Levels

Meeting global regulatory requirements demands a high level of expertise and consultative support, with validation often involving many steps. To help you choose the right validation package, BioReliance® Validation Services offers two levels of service for better value and a better experience. Our standardized packages make your life easier with these benefits:

  • Clear and predictable budgeting
  • Greatly simplified service selection, at the right time and phase of development
  • Globally harmonized testing
  • Precisely as much help as you need, with our trademark commitment to expert testing, compliance, and support

Whichever you choose, our validation experts will be with you at every turn.

Choose from Classic or Advanced packages

We’ve simplified your process from the start with two predefined service levels.

  • Classic: Rely on us for guidance. We’ll do what’s required to get your validation study done – with the highest quality standards.
  • Advanced: Let’s collaborate. We’ll discuss your specific requirements and customize a validation plan that works for your advanced needs and complex studies.

1 Classic testing covers predetermined range of process conditions with defined study parameters. Advanced testing provides higher level of customization including process conditions,
additional test equipment/resources and more complex study requirements.
2 Drug product and Process information fields.
3 Validation summary report is integrated when two or more services ordered.

Discover an easier way with BioReliance® Validation Services. Contact us to request a quote or discuss the service level that is right for you.

Choosing the Right Validation Services

Choosing the Right Validation Services

Related Product Resources

Data Sheet: Test Parameters by Service Level
BioReliance® Validation Services Global Brochure

Related Services
Emprove® Program
Confidently speed your way through the regulatory maze and fast track your new drug to market with the Emprove® Program. High-quality products, comprehensive documentation, and superior customer support facilitate your efforts in qualification, risk assessment, and process optimization.
Single-Use and Filter Validation Services
Accelerate and simplify your path to market by using our BioReliance® Validation Services to select, test, and validate your filters, assemblies, and single-use systems for drug manufacturing and processing.
Bacterial Retention Testing
Required by regulatory bodies worldwide, bacterial retention testing (BRT) is a critical step in filter validation. Our skilled validation specialists conduct BRT using each end-user’s worst-case biopharmaceutical processing conditions to ensure a best-case outcome.
Chemical Compatibility Testing
Our physical and chemical compatibility testing services help you comply with GMP guidelines worldwide, proving that your biopharmaceutical filters and single-use systems are not reactive, additive, or absorptive upon contact with drug product.
Filter Integrity Testing
Our integrity testing for sterilizing-grade filters can help you set a test specification for your drug product, then check for leaks or filter damage using pre-use and post-use testing as recommended or required by regulatory agencies and the Parenteral Drug Association (PDA).
Extractables and Leachables
Proving that extractables and leachables from your process aren’t harmful to the final drug product is easier with BioReliance® Validation Services. Our extractables and leachables (E&L) services thoroughly evaluate all contact materials and processes to mitigate concerns about process fluids.
Related Product Categories
Prefilters & Bioburden Control
Prefilters are used to remove particulates and protect downstream unit operations. They can be used to provide column protection or in front of a sterilizing-grade filter to improve capacity. Learn how our cost-effective prefilters can enhance your process economics.
Single-Use Assemblies
Mobius® 2D and 3D single-use assemblies and systems for sterile fluid management offer flexible manufacturing options for biopharmaceutical companies, from frozen transport and storage, media and buffer preparation to final fill applications.
Related Applications
Monoclonal Antibody Manufacturing
Monoclonal antibody manufacturing is a highly templated approach used to produce mAb-based immunotherapies. Robust, scalable process solutions are required at every step to ensure high therapeutic concentration and process safety, while meeting speed-to-market and cost containment concerns.
Classical Pharmaceutical Formulation & Manufacturing
Manufacturing the final dosage form of a small molecule drug requires robust quality and design in development of the formulation and production of the final product. Explore solutions and best practices to advance and accelerate small molecule pharmaceuticals, from development to commercialization.
Gene Therapy Manufacturing
Growing use of gene therapies is driving rapid innovation in an evolving global market. Manufacturers bringing new gene therapies to life face complex challenges, requiring an experienced partner capable of integrating vector manufacturing, testing, safety, process development, and regulatory compliance.
Vaccine Manufacturing
From early phase development, through downstream purification to large scale vaccine production: learn more about vaccine process development and application expertise.
Sign In To Continue

To continue reading please sign in or create an account.

Don't Have An Account?