Regulatory Affairs

Achieve quick regulatory approval and market access for your product; leverage our unparalleled scientific, regulatory, and operational expertise

About Regulatory Affairs service

Regulatory services from AstaLynx span the full spectrum of activities that includes regulatory development, licensing and life-cycle management, regulatory strategy input and full-service regulatory partnerships.

Our process improvement approaches ensure quality of delivery, every time.

Regulatory affairs play a major role in the product lifecycle

Our regulatory affairs team is capable of understanding the different regulatory environment, ensuring compliance with regulation, and understanding opportunities for applicable regulatory requirements over the course of product development life cycle.

Our regulatory affairs team comprises of experts in the preparation, compilation, and delivery of regulatory submissions.

The regulatory services we offer include

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Regulatory Intelligence

Artwork

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Variations

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Product Development

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Dossier Preparation and Submission

Post-submission Activities

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Product Registration

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Labelling

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About our Medical Affairs service.

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Publishing

Handling Regulatory Queries

Learn more about our Regulatory Affairs services