Healthiza’s Drug Regulatory Affairs professionals assist you to overcome any obstacles on the way to regulatory approval for current or newly created pharma products. We assist our customers in determining the best registration strategy for the products we create and manufacture. From analyses to quality cGMP compliance, we have the capability to provide experienced clinical and regulatory support across all aspects of global drug development through commercialization. We create all regulatory papers and oversee change management after approval. Our ability to manage high-quality dossiers ensures that approvals are received on schedule. We have the capacity to assist clinic and regulatory efforts in the United States, the European Union, Asia Pacific, and Latin America.
Our expertise areas include all segments of pharma product, food-dietary supplements and medical devices. We assist you with marketing authorization applications, such as those submitted under Directive, generic applications, hybrid applications, and well-established use applications, by organising and administering the whole marketing authorization or providing only the elements that are required.
Regulatory Science Expert Consulting Services
- The world’s leading regulatory consulting firm
- Drugs, Biologics, Medical Devices, and Diagnostics
- Support throughout the Lifecycle
- Pre and Post Approval
Covering all regulatory requirementsFrom the initial application to post-approval actions, our regulatory services span the complete regulatory lifecycle. Our regulatory professionals are involved in the research and development phase to verify that the subsequent registration processes operate smoothly and efficiently. We can get our clients’ products to market faster because of this holistic strategy.
OUR PERFECT REGULATORY SERVICES ASSIST YOU IN MAKING PERFECT REGULATORY SUBMISSIONS THE FIRST TIME.
- With over 20 years of expertise, we have successfully executed a large number of regulatory applications for pharmaceutical and medical device firms all over the world.
- Our lean, efficient, and cost-effective collaboration strategy is designed to provide a smooth approval process while lowering the risk of non-compliance/de-licensing.
- Helthiza works with pharma companies of various sizes, from small to large.
- We may create custom outcomes-based pricing engagement models for you.
Get in touchAre you ready to learn more about how Healthiza may help your company become more productive, responsive, and flexible?
Please do not hesitate to contact us and we will respond as quickly as possible.