Regulatory Compliance and Its Impact on Pharmaceutical Startups’ Growth

Dr. Sandeep Kumar

DCSE

Tula’s institute

Dehradun, Uttarakhand India

sandeepkumarsiet@gmail.com

Abstract

This study investigates how regulatory compliance affects the growth trajectories of pharmaceutical startups. With rapid technological advances and evolving global health challenges, startups in the pharmaceutical sector face a uniquely complex landscape shaped by stringent regulatory frameworks. This research explores the dual role of regulations: while compliance ensures safety and market integrity, it also imposes significant administrative and financial burdens. Utilizing a mixed-methods approach, the study combines quantitative analysis from a survey of 50 startups with qualitative insights from in-depth interviews. Results indicate that while adherence to regulatory standards enhances credibility and long-term sustainability, short-term growth may be slowed due to increased overhead costs and extended product development cycles. The findings underscore the importance of adaptive regulatory strategies and propose a framework to assist startups in navigating these challenges.

Keywords

Regulatory Compliance; Pharmaceutical Startups; Growth; Quality Assurance; Innovation; Market Access

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