CMC, Dossier Compilation & Regulatory Support
We at Healios recognize this maze; that is, the complexities and strict regulations for compliance. With our expert team on your side, they will help you every step of the way in navigating each nuance while utilizing our experience to guarantee your products have a smooth and successful market entry. Discover how our regulatory support services can turn issues into strategic strengths.
Regulatory Filing as a Critical Pathway to Approval
Market access begins with regulatory filing, your golden ticket to entry. We have a very rigorous approach and that involves preparing and submitting the documentation to the standards and regulations that are applicable to them. Healios becomes a partner for you to address the risks of compliance and focus on what you do best – developing high quality pharmaceutical products.
Regulatory Registration for Global Market Access
In order to enter markets such as United States, European Union, Canada, Brazil, or Australia, one needs to know about certain regulatory framework. We have a specialized team with an in depth understanding and knowledge of the local requirements for pharmacovigilance, labeling and safety regulations. We are your strategic passport to international market entry, enabling your ambitions to become global.
ANDA and Dossier Registration Streamlined for Regulatory Efficiency
The Abbreviated New Drug Application (ANDA) process is filled with complex challenges. We accelerate the registration pathway by helping to prepare and submit complete dossiers across different jurisdictions. We completely cover from meticulous documentation to strategic regulatory insights covering the overall way to get approvals in a cohesive way, in an efficient way.
Variation Filing for Agile Regulatory Adaptation
Our variation filing services are geared towards making agile adaption in an everchanging pharmaceutical landscape. We address change in active pharmaceutical ingredients (APIs), alternative sources, etc., and guarantee timely and compliant submissions. We specialize in facilitating your ability to operate with changes, thanks to our expertise in what it means to be regulatory flexible.
Post-Authorization Changes for Continued Compliance
Once market approval is obtained, there is a need to effectively manage post authorization changes. We can provide services for strategic assessments and submissions of variations for changed formulation, manufacturing process and labeling changes. We make sure that these changes are conducted within regulatory standards and do not damage the integrity of your product, and you remain able to adapt to market dynamics.
Partner with Healios for Regulatory Excellence
Are you ready to transform regulatory burdens into competitive advantages? Let’s partner together at Healios where compliance and innovation dance with scientific rigor. We will help you together in navigating through the regulatory maze, while keeping your products ready for success in the competitive marketplace.