About Us

Overview

Edenwell Therapeutics Private Limited, established in 2017, is a distinguished Life Sciences Organization specializing in the development of specialty drugs and provision of comprehensive clinical research services. Committed to advancing healthcare, Edenwell actively supports clinical trials spanning from Phase I to Phase III and extends its services beyond product registration and commercialization. These include Phase IV regulatory studies and Post Marketing Studies (PMS). The organization excels in a broad spectrum of offerings, encompassing clinical operations, project management, site feasibility, end to end regulatory services, data management and medical writing services.

Edenwell boasts an indisputable record of excellence across the pharmaceutical, FMCG, Biotech and medical device sectors. Operating from its Mumbai office, the company is equipped with a seasoned team of professionals drawn from diverse backgrounds in science and medical education.

Edenwell Therapeutics stands out as a reliable partner, showcasing the capability to address all clinical requirements of its clients. It ensures optimal outcomes at a minimal cost, upholding the highest standards of quality and ethics in the generation of data throughout the entire process.

Our Vision

Our vision is to contribute to the global advancement of medical science and serve the society through continuous efforts and improvement in the drug development and clinical research services.

Our Mission

Our mission is to provide customized and advanced strategic solutions to all partners at low costs with highest quality and ethical standards in shortest span of time.

Who are we

After navigating a significant journey since its inception in the year 2017, Edenwell has undoubtedly experienced fruitful outcomes. Focused on our unwavering vision and mission, the company persistently contributes to the global healthcare industry. Highlighted below are key milestones marking the company’s trajectory of consistent growth.

2017

Foundation of Edenwell by Dr. Parvez Kosgi & Kamlesh Londhe

2018

Entry of one more partner to promote Edenwell’s growth

2019

1. Introduced Monitoring Services for BA/BE & PK studies 2. Qualified as Preferred Partner by one the largest Pharma company 3. Monitored more than 75 BA/BE studies

2020

1. Global Strategic Partnership with with one of the largest global CRO’s 2. Succesfully more than 50 BA/BE studies

2021

1. Initiated one of the largest global Phase III study in CML patients across 40+ sites 2. Monitored more than 85 BA/BE studies 3. New Office in Vikhroli

2023

1. Succesfully completed enrollment for CML study 2. Monitored more than 30 BA/BE studies

Leadership

Edenwell stands as a pioneering force in the industry, boasting an indisputable track record of excellence in providing end-to-end clinical research services to the pharmaceutical, FMCG, and medical device sectors. However, the foundation of this success lies squarely on the shoulders of Edenwell’s management team — a group comprised of some of the finest industry experts. Their expertise and leadership have been instrumental in realizing and sustaining the company’s commitment to delivering exceptional services across the spectrum of clinical research.

Dr. Parvez Kosgi

Dr. Kamlesh Londhe

Dr. Shoeb K

Dr. Sunil Chaudhry

Dr. Chandra Viswanathan

Because It Has to Be Right

Quality Assurance

The Quality Assurance Department at Edenwell is dedicated to fulfilling the needs of our customers, including those of peers, sponsors, and regulators.

Quality Assurance Auditing is a cornerstone of our approach, involving regular audits of systems, studies, and vendors based on comprehensive risk assessments. Our department actively addresses non-compliances, managing events unrelated to audits through root cause analyses and corrective and preventative actions (CAPA).

GXP Training is a continuous focus for our Quality Assurance Department, offering regular training sessions to staff on GXP and other standards. Ad-hoc coaching is also provided in areas that may benefit from additional support.

Edenwell maintains a centralized Quality Management System (QMS) with Standard Operating Procedures (SOPs) and Company Policies. Adherence to these standards is rigorously monitored by managers and the Quality Assurance Department, ensuring standardization across all activities.

Track Record Clinical Research proudly maintains a consistently excellent track record marked by high quality; a testament supported by feedback from external sources. This strong track record underscores our unwavering commitment to maintaining the highest standards of quality across all facets of our operations.