Ensuring product stability and compliance

Stability studies ensure that a product — whether a drug, medical device, or OTC product — retains its characteristics over time under controlled environmental conditions.

We support your projects with ICH stability studies, as well as preliminary stability studies, at every stage of their lifecycle.

Our infrastructure combines various climatic chambers with precise temperature and humidity monitoring via dedicated software, while ensuring complete traceability, both software-based and physical, for each batch.

Preclinical and clinical development

Pre-stability studies

Regulatory submissions

MA, CE... degradation, in-use, excursion

Post-marketing surveillance

Ongoing

Stability study services

We offer comprehensive support:

Preliminary stability studies

In formulation and industrialization phases

ICH stability studies

According to climatic zones I to IV, long-term, intermediate, and accelerated

VICH stability studies

For veterinary medicinal products, with specific conditions

Ongoing stability monitoring

Monitoring of commercial batches as part of market surveillance

Protocol and sample management

Drafting study plans, secure storage, analytical monitoring

Controlled ICH climatic zones

We conduct your stability studies in qualified climatic chambers, covering all zones defined by ICH guidelines.

Each chamber is equipped with a continuous monitoring system and alarms to ensure sample integrity.

25°C

60% RH

25°C

40% RH

30°C

65% RH

30°C

75% RH

30°C

35% RH

30°C

70% RH

40°C

75% RH

40°C

25% RH

5°C

-20°C

Why choose Unither Pharmaceuticals for your stability studies?

Adapted capacity

for pharmaceutical and veterinary studies

A range of climatic conditions

to cover all regulatory needs

Dedicated project management

from protocol to final report

Integrated analyses

performed in our GMP-compliant laboratories

Recognized expertise

in regulatory support and CMC documentation

FAQ - Pharmaceutical stability studies

Yes. We offer post-market monitoring (ongoing stability) for batches that are already on the market.

We have many chambers covering climatic zones I to IV, as well as refrigerated and sub-zero conditions (5 °C, –20 °C).

Yes. We can conduct VICH studies that are compliant with specific veterinary medicine guidelines at our site in Bordeaux, France.

It is a study conducted according to ICH Q1A guidelines, which define climatic conditions and time periods for demonstrating the stability of a pharmaceutical product.