Analytical Method Development and Validation

We specialize in the development and validation of robust analytical methods tailored to meet the stringent requirements of various regulatory bodies, including the USFDA, ICH, and WHO etc. Our expert team combines deep scientific knowledge with advanced technologies to ensure precise, reliable, and compliant results for the pharmaceutical, biopharmaceutical, and packaging industries.

Our Capabilities Include:

Method Development:
Custom development of analytical methods tailored to your specific needs, ensuring accuracy and reproducibility.
Method Validation:
Comprehensive validation processes to confirm that analytical methods meet all regulatory standards and are fit for their intended use.
Regulatory Compliance:
Adherence to guidelines from FDA, EMA, ICH, WHO, and other global regulatory bodies.
Robust Testing:
Utilizing state-of-the-art technologies such as HPLC, GC, GCMS, LCMS, ICPMS etc., more to deliver high-quality results.
Comprehensive Documentation:
Detailed documentation and reporting to support regulatory submissions and audits.

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Apta Labs Pvt Ltd is a premier contract research and testing laboratory providing a comprehensive range of services to the pharmaceutical, biopharmaceutical, and packaging industries.