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Regulatory Affairs

What we do

We help clients achieve positive regulatory outcomes using a scientific approach as the driver of success. As the world’s leading provider of regulatory consulting services, we support our clients from pre- through post-approval for both the Middle-east and North Africa region.

Our Services

REGULATORY CONSULTING/SUPPORT

  • Experts in the development, approval, and post-approval stages of a product’s lifecycle

REGULATORY MEDICAL AND TECHNICAL WRITING

  • The in-house team of domain-specific subject matter experts helps clients produce clear and suitable regulatory documents

STRATEGIC LABELING

  • Help companies to complete labeling activities for their products, ensuring regulatory and legal compliance as well as competitive labeling for marketing purposes

Why choose ESEN

We develop regulatory strategies for your product, providing a clear path forward through all the critical milestones to achieve a successful outcome. We can also help with your post-authorization regulatory needs, including the launch of your product, line extensions (LE) and variations, and maintaining your products’ optimal regulatory status throughout its lifecycle.

ESEN Advantage:

Regulatory Affairs Services provides assistance throughout the development, approval, and post-approval stages of a product’s lifecycle. Our team has extensive experience helping companies achieve the necessary preparation and compliance as required by the FDA, EMEA, and other global regulatory bodies. Solutions are customized to suit each client; ranging from supplementary support to a client’s existing team through to a complete outsourced regulatory affairs function.