Axis HealthCare Latin America Consulting provides strategic guidance during the drug development process, market authorization submission, pre- and postapproval, and market access to overcome obstacles to get products to market faster and more smartly. Our scientific & technical, regulatory, and commercial market access expertise puts proven best practice to work for clients. We work to design solutions to regulatory issues in the constantly evolving Latin American regulatory environment and commercial landscape. We work to ensure regulatory compliance by strictly adhering to National requirements and procedures that may apply to pharmaceuticals, medical Devices, biologics, and combination products.
Custom Guidance for National Market Presence
At Axis HealthCare we work to develop sound regional product development and portfolio strategies that leverage both regional and local specialized expertise in country resources to gain the competitive advantage essential to commercial success.
Axis HealthCare develops practical customized regulatory strategies to support your company business strategy that takes into account key compliance aspects of the regulatory procedure into account to ensure a smooth path to approval as well as preparing a solid foundation for the product.
Axis HealthCare’s network of internal and external experts and services covers the full spectrum of communication channels to extend your outreach and strengthen your relationship within the regional scientific, and medical expert communities in key countries.
At Axis HealthCare our local experts look to identify key clinical, technical, logistical, or regulatory concerns that must be clearly addressed to ensure an eventual commercial advantage as early as in phase III of the developmental process.
Capturing local / regional clinical trial idiosyncrasies and ensure alignment with international ethical and scientific quality standard for the design, conduct, and recording trials that involve human subjects. Identifying and weighing the risks against anticipated benefits.
Axis HealthCare Medical Communications’ expertise spans in data analyses, market scoping, and strategic communications planning we integrate your evidence into an insightful, comprehensive, and industry compliant communications program.