Health and Life Sciences Market Access

To achieve market access, manufacturers of pharmaceuticals, medical devices and other medical products must demonstrate compliance with regulations, as well as quality, safety and performance standards and related requirements in their target markets. Companies must also keep up with changes to regulations and standards in order to maintain market access once they successfully register their products.

Medical product manufacturers may want to consider which of the largest medical markets — the U.S., Europe, Japan — to target first, as well as how market access in these jurisdictions could mean expedited market pathways in other countries. Manufacturers should also consider factors such as the depth and breadth of their in-house expertise and capacity to automate regulatory affairs processes.

Regulatory affairs entail supporting ongoing compliance of medical products to all relevant regulations in markets where those products are registered for sale. For manufacturers of medical devices, in vitro diagnostic devices (IVDs), pharmaceuticals and biologics, regulatory affairs include market access submissions to regulators, product life cycle management and post-market surveillance to maintain market access.