Estima Pharma Solutions LLP

In their own words

Estima Pharma Solutions LLP is a top line Pharmaceutical GMP and Regulatory Consultants in India engaged in providing Total Pharma Solutions extending to Green Field Projects, setting up of Pharma manufacturing facilities, Pharma Designing and Engineering, Qualification and Validation, Product Development, Contract manufacturing, Third Party Audits, Marketing Solutions for Europe, Middle East, USA, BABE and clinical monitoring including outsourcing of studies and Data Integrity solutions. We are established to provide total pharma business solutions to new horizons worldwide, having worked closely with our clients to successfully clear 45 international regulatory audits till date. While focus is to constantly deliver a broad spectrum of competencies laying emphasis to International Standards on GMP guidelines in compliance with various International Regulatory Authorities for manufacturing companies in South Korea and Vietnam, we are progressively expanding in other geographies as well. We operate our wherewithal from India in adherence to the national and international regulatory requirements while committed to quality, efficiency, confidentiality and competitiveness to foster long term partnerships with clients. We always strive to deliver cost effective, ergonomic services with uncompromised quality under defined timelines. Above all, we also offer innovative capital solutions to emerging pharma, biotech and virtual companies in terms of profit sharing, fixed costs variable, decision making and human capital. Our Services Comprehensive Engineering Solutions - Greenfield & Brown Field Projects GXP Audits and Expertise Establishment and Implementation of Quality Management Systems GAP Analysis With Respect To All International Regulatory Requirements Qualification and Validation of Facilities, Equipment’s And Utilities Dossier Preparation and Submission Triggering Of Any International Regulatory Audits Training and Development Data Integrity Solutions in Pharma Panel Advice For US FDA-483Our Experts also offer Panel Advice For US FDA-483 Observations And Warning Letters (Analysis And Its Implications): Review of FDA Form 483 issued to manufacturing plant for significant, questionable observations during course of inspection and judgment that constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts indicating specific and significant practices indicating final product adulteration thus compromising safety on human health. Establish comprehensive discussions with company’s management on full understanding of the observations, evidence collected on site during inspection, expeditiously address nature of response and suggestive implementation of corrective action plan. Review warning letters notified for exclusive violation of the US FDA act with respect to practices, processes, or other activities of regulatory significance, federal statutes, leading to an enforcement of viable action if such documented violations are not adequately or appropriately corrected to determine and protect public health.

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