SIMA LABS is NABL accredited and approved under FSSR and BIS for conducting stability testing in compliance with ICH Q1A(R2), WHO, USFDA, EMA, and CDSCO guidelines. Our stability studies ensure accurate determination of product shelf life, storage conditions, and re-test periods, supporting both domestic and international regulatory submissions.

We provide comprehensive stability testing services for pharmaceuticals, biologics, and related products under controlled environmental conditions.

Scope of Testing:

• Study Types:

  • Accelerated stability studies

  • Long-term stability studies

  • Intermediate condition studies

  • Photostability testing (ICH Q1B)

  • In-use stability testing

• Environmental Conditions Simulated:

  • 25°C / 60% RH (Long-term)

  • 30°C / 65% RH (Long-term for subtropical climates)

  • 40°C / 75% RH (Accelerated)

  • Custom conditions as per product requirements

• Products Covered:

  • APIs

  • Finished dosage forms (oral, injectable, topical, ophthalmic, etc.)

  • Biopharmaceuticals

  • Packaging systems and materials

• Technology & Facilities:

  • Validated stability chambers with continuous temperature & humidity monitoring

  • Data logging with 21 CFR Part 11 compliance

• Regulatory Compliance:

  • ICH Q1A(R2), Q1B, WHO stability guidelines

  • USP, EP, BP, IP standards

With state-of-the-art stability chambers, validated protocols, and expert analytical support, SIMA LABS ensures your products remain safe, effective, and compliant throughout their intended shelf life.