End-to-end regulatory affairs, operations, and lifecycle management.

Providing you with regulatory strategy, labeling, publishing, and intelligence solutions supported by our global expertise, data and technology, from early drug development through submissions and post-registration.

We guide and assist pharmaceutical, biotech and healthcare companies in the design and implementation of innovative and global regulatory strategies in order to expedite product development and registration of drugs, biologics, medical devices, combination products, and other healthcare products for all stages of development. We are a team of experienced regulatory professionals in Australia, US and European regulatory environments providing regulatory support for products in all stages of development (preclinical to post-market). We collaborate with companies to bring products to the market in the most efficient and cost-effective manner, within an evolving and increasingly challenging regulatory environment.