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Capabilities
Regulatory History
Our company has a proven record of success when it comes to regulatory audits. We have undergone over 100 audits by various Regulatory Authorities such as DCGI, USFDA, WHO, EMA, ANVISA and NPRA-Malaysia.
Our commitment to compliance and quality assurance is unwavering, and we take great pride in our track record of success.
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Quality System & Team
- Our quality system ensures adherence to GCP & GLP guidelines.
- The quality team conducts study-based, facility-based, and process-based audits to ensure everything is in order.
- Quality team works closely with the all teams to investigate any issues that may arise and implement corrective and preventive actions (CAPA) as necessary.
- Our quality team is the face of our organization during sponsor and regulatory inspections and audits, representing us with professionalism and integrity.
Clinical
We have three clinical facilities located in Mumbai, Ahmedabad, and Vadodara. All of them have obtained the necessary regulatory approvals, ensuring the highest levels of patient safety.
Mumbai
- 122 Beds
- 3,400 Sq. Ft
Ahmedabad
- 94 Beds
- 3,800 Sq. Ft
Vadodara
- 140 Beds
- 7,600 Sq. Ft
Bio Analytical Lab
- Our company is proud to have a dedicated bio-analytical laboratory with highly skilled scientists who are able to execute projects flawlessly.
- We have seen the lab's efficacy firsthand, as they have successfully developed assays for challenging molecules using high-end equipment.
- One of the key advantages of this lab is its ability to handle multiple projects at once, thanks to its well-designed layout and state-of-the-art equipment. Additionally, the lab is able to face multiple audits simultaneously, ensuring that our work meets the highest standards of quality and safety.
Validated Assays (BA/BE)
Our assay bank has an extensive collection of over 1000+ bioanalytical methods.
Each method has been meticulously developed and validated in strict compliance with international regulatory requirements.
These methods encompass a wide range of chromatographic techniques enabling us to accurately assess drug concentrations.
Our portfolio of validated bioanalytical methods enables us to support diverse research programs, clinical trials, and drug development processes while ensuring the highest quality and regulatory compliance standards.
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Biologics Lab
Our laboratory conducts comprehensive clinical assessments of comparability using Immunogenicity, PK, PD assays that utilize the ELISA assay format.
Additionally, we possess the necessary equipment to analyze the structure and properties of biologic molecules for protein characterization.
We have the capability to evaluate the potency and biological activity of biologic drugs through bioassays.
Our collection of cell lines enables us to conduct a diverse range of Bioassay experiments and studies.
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