Axis HealthCare Local Regulatory Compliance experts have 15 to 20 years of local country experience with demonstrated record of identifying and mitigating risk. The team is always available and prompt to respond locally to any crisis, to avoid product approval delays, recalls, or having to undertake costly repetitive regulatory actions.
In an ever more demanding Latin American regulatory environment noncompliance is an expense that no healthcare company can afford. Axis HealthCare’s experienced team is composed of former heads of Country Regulatory Affairs Organizations for major US or EU pharmaceutical companies and quality professionals who offer time-tested solutions for any issue that your companies could face.
Axis HealthCare develops practical customized regulatory strategies to support your company business strategy that takes key compliance aspects of the regulatory procedure into account to ensure a smooth path to approval as well as preparing a solid foundation for a fully compliant life cycle management of product commercialization. We design local strategies that preemptively avoid any compliance issues or situation of crisis management.