Compliance Assurance

We, at Elexes have a team of experts who would make sure that your biologics or drug is in compliance with all the applicable regulations. We also help biologics and pharmaceutical companies develop a sustainable compliance strategy for their product to expedite the clearance/approval process.

Our experts can help you at each step of the compliance assurance journey. Be it assessments or preparation for inspection.

Pharma & Biologic Assessment Support

Our experts have years of experience in helping pharma and biologics companies to stay compliant with all the regulations of the market they wish to target. We have a dedicated team who follow through all the assessments to ensure there are no compliance gaps.

From cGMP assessment, Corrective and preventive Action (CAPA), Investigations and deviations, Facility and maintenance assessment, and data integrity assessment to quality system gap assessment, our compliance assurance program offers all kinds of services to Biologic and Drug manufacturers.

Inspection Readiness & Preparations

Another fold of our compliance assurance services for Biologics and Drug companies is preparing you for regulatory inspections. Our experts have years of experience to ensure that your product is all set for the regulatory inspection by the desired regulatory body.

Our inspection readiness services include:

If you are among those biologics or drug companies who wish to get best compliance assurance program, all you have to do is contact us and we will assist you through the entire regulatory clearance & approval journey.

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