Edenwell is led by an experienced, multi-disciplinary team with deep roots in clinical research, regulatory affairs, and business strategy. Our Scientific and Advisory Board brings together domain experts in regenerative medicine, medical affairs, regulatory science, hospital development, and finance.
Responsible for business operations, clinical oversight, and client engagement. 20+ years experience.
Dr. Shoeb Kosgi is a co-founder and Director of Edenwell Therapeutics, responsible for strategic direction and long-term business development. His vision for building an integrated, ethics-driven CRO has shaped Edenwell’s growth trajectory from inception.
Hasib Kosgi leads Edenwell’s innovation agenda and inorganic growth strategy, identifying opportunities for strategic expansion, partnerships, and capability enhancement across the clinical research value chain.
Deepak Gowda serves as a strategic advisor and Director, overseeing technology integration, financial strategy, and business development, including mergers and acquisitions.
A leading authority in regenerative medicine, Dr. Viswanathan brings deep scientific expertise in stem cell research and advanced cell-based therapeutic approaches to Edenwell’s scientific leadership.
A leading authority in regenerative medicine, Dr. Viswanathan brings deep scientific expertise in stem cell research and advanced cell-based therapeutic approaches to Edenwell’s scientific leadership.
A leading authority in regenerative medicine, Dr. Viswanathan brings deep scientific expertise in stem cell research and advanced cell-based therapeutic approaches to Edenwell’s scientific leadership.
A leading authority in regenerative medicine, Dr. Viswanathan brings deep scientific expertise in stem cell research and advanced cell-based therapeutic approaches to Edenwell’s scientific leadership.
A leading authority in regenerative medicine, Dr. Viswanathan brings deep scientific expertise in stem cell research and advanced cell-based therapeutic approaches to Edenwell’s scientific leadership.
A leading authority in regenerative medicine, Dr. Viswanathan brings deep scientific expertise in stem cell research and advanced cell-based therapeutic approaches to Edenwell’s scientific leadership.
Our Story u2014 From Startup to Global CRO
Relocated to a dedicated office in Thane West. Successfully completed a quality audit by a leading Indian pharmaceutical company, resulting in the award of our first third-party clinical monitoring services contract.
Entered a phase of structured growth: expanded our technical workforce, strengthened service delivery capabilities, and established a long-term preferred monitoring partnership with a domestic pharmaceutical client.
Maintained uninterrupted service delivery through the pandemic period. Demonstrated operational agility by rapidly adapting to compliant remote-monitoring and hybrid operational protocols. Sustained revenue growth above pre-pandemic baseline.
Awarded a landmark multi-million dollar contract with a large international pharmaceutical sponsor for the execution of a global Phase III oncology trial in India. Successfully passed a remote international QA audit; secured DCGI approval; defended protocols at SEC Oncology meetings; obtained Clinical Trial and Import Licence approvals. Revenue classified as export of clinical research services u2014 generating direct foreign exchange inflow into India.
Concurrently executed Phase IV study support and medical writing/regulatory documentation engagements. Fully repaid all startup liabilities within six months, transitioning to a debt-free, financially independent status.
Successfully managed the regulatory roadmap for complex biological products (rFSH and Dengue Vaccine) for a leading Indian multinational pharmaceutical company, demonstrating Edenwellu2019s capability to handle high-barrier biologicals and vaccines. Progressing toward closure of the global Phase III oncology study while maintaining active business development across India and international markets.
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 u2014 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.
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.
