Regulatory Affairs/Operations Management and Consultancy

Life sciences industry is faced with a significant challenge in meeting the demands of ever-increasing regulatory requirements. As regulations become more complex, it takes more time, resources, and expertise to comply with them.

eSA offers comprehensive regulatory operations services, from product registration to post-approval maintenance, to ensure efficient and effective regulatory compliance. With a talented team of regulatory experts and extensive delivery capabilities, eSA can deliver outstanding outcomes such as increased resource scalability, quicker market entry, enhanced compliance, and process excellence.

Our support include:

• Global submission strategy, preparation and leadership focused on incorporation of regional regulatory requirements
• Submission planning and management
• Regulatory submission road maps
• Strategic support in identifying the optimal pathway for different types of applications in the global market
• Identification of Regulatory compliance requirements and mitigation plans for the targeted countries.
• Meet clients’ geographical needs with flexible working hours

And more…