We offer a broad range of analytical services for complex research needs. We perform method development, validate and transfer Good Manufacturing Practice (cGMP) compliant methods for a broad spectrum of pharma compounds. We also perform stability analysis of drug products and active ingredient (APIs), packaging as per ICH, quality control testing and release as per cGMP requirements.
Our team is capable of providing documentation support – CMC, IND-CTA, MAA and DMF in line with the regulatory requirements across the globe.
Equipped with one of the best infrastructures in India for Analytical services, GVK BIO is well positioned to meet the needs of complex analytical challenges.
Robust analytical method is one of the keys to quality product development and faster regulatory approval. At GVK BIO, we develop product specific analytical methods, which are best suitable for intended use of application with an approach of ‘right first time’. We help our partners globally to develop various analytical methods at efficient cost and meeting global quality and regulatory standards.
Our analytical services team develops all methods based on a thorough scientific literature search and review, which leads to appropriate selection of analytical technique and development design for the targeted product/analyte. Performance of Instruments is ensured throughout the experimentation, which is handled by highly trained and skilled analysts. Robustness testing and key preliminary validation performance parameters are integral to our development design method.
We excel in development of In-Vitro dissolution methods, which plays a critical role in drug development process especially for Solid oral dosage forms where absorption of drug is necessary. We take great care while establishing a discriminating dissolution method with emphasis on following key elements:
- Dissolution media selection based on pharmacokinetic parameters
- Relevance to In-vivo performance
- Sink conditions
- BCS Classification of API
- Selection of relevant analytical technique