Clinical Registration & Annual Stability Studies

ICH-Aligned Testing to Support IND/NDA Filings and Ongoing Shelf-Life Verification

Clinical registration stability studies and annual stability testing are designed to establish and confirm product shelf life under long-term and accelerated conditions. These programs generate GMP stability data that support regulatory filings, label claims, and ongoing quality verification. The accuracy of these studies depends on both controlled storage and consistent analytical execution.

At BA Sciences, we manage long-term stability studies for investigational and commercial drug products using validated methods, controlled material handling, and ICH-compliant stability chambers.

Contact Us

"*" indicates required fields

Name*
Company Address*
This field is for validation purposes and should be left unchanged.

Clinical Registration & Annual Stability Services

Clinical registration stability studies are conducted to support IND, NDA, and ANDA submissions. Studies are designed to meet ICH Q1A(R2) requirements and can be structured for a wide range of dosage forms and packaging types.

Available testing includes:

  • Expiration date testing
  • Chemical stability testing (assay, impurities, degradation products)
  • Microbiological stability purity testing (bioburden, sterility, endotoxin)
  • Pharmaceutical API stability testing
  • Physical evaluation (appearance, pH, color, particulate content)
  • Packaging interaction and container closure testing

Study designs may include long-term (25°C/60% RH), intermediate (30°C/65% RH), and accelerated (40°C/75% RH) storage conditions, as well as customized temperature and humidity conditions.

Annual Stability Testing and Ongoing Monitoring

Annual stability testing programs are required to support ongoing product release and shelf-life claims after initial registration. We manage annual studies under defined protocols with sampling plans aligned to regulatory expectations and client SOPs.

All samples are stored in validated ICH-compliant stability chambers with continuous temperature and humidity monitoring. Testing is performed under cGMP and documented using validated LIMS and ELN systems; all chambers are on a back-up generator system to ensure condition continuity.

Why Work with BA Sciences

With over 35 years of experience in pharmaceutical shelf-life testing, our team supports stability programs from clinical development through post-approval commercialization. All test methods are validated, and protocols are managed under formal documentation and change control.

What we offer:

  • ICH Q1A(R2)-aligned clinical registration stability studies
  • Protocol-based annual stability testing for ongoing shelf-life verification
  • Access to qualified ICH-compliant stability chambers
  • Consistent GMP stability data with traceable documentation
  • Automated photostability and freeze-thaw chambers

Our team works with your stability protocols or helps establish new ones to ensure audit readiness and regulatory alignment.

Request a Stability Study Quote

To request a quote for clinical registration stability studies or set up annual stability testing, contact us. Our team can review your protocol and storage requirements.

Ready to get started? Tell us about your upcoming project

Get an Accurate, Timely Quote
Tell Us About Your Project