The pharmaceutical industry is greatly affected by policies. In recent years, the pharmaceutical management departments of various countries have carried out drastic reforms in the pharmaceutical industry. In terms of drugs, they have accelerated drug approval, improved the quality and availability of drugs, increased industry concentration, and avoided low-level duplication. Avoiding waste of R&D resources is conducive to the healthy development of the pharmaceutical industry. The US FDA also has a more stringent complete set of certification procedures for pharmaceutical products to ensure the safety and effectiveness of new drugs.
Our company registration team aims to concretize the client's drug development work into regulatory tangible assets. In the process, it can help pharmaceutical companies increase asset valuations, strengthen investment attractiveness, and clarify exit options.
The company's regulatory services include but are not limited to:
Orphan Drug Designation (ODD)
Breakthrough Therapy Designation (BTD)
Expedited Approval
Fast track Designation
Strategic Roadmap
IND and NDA Submission
Rare Pediatric Disease Designation
Priority Review Certificate
Annual Report
In the process of international growth, it is inevitable for companies to meet the different regulatory requirements of various countries for product registration. Reasonable and flexible use of international regulations will make subsequent product listings more effective. Our company hopes to provide assistance for more small and medium-sized enterprises to enter the international market through our company's own platform.