Regulatory affairs
Celestial facilitates regulatory supports to gain access to the Asian markets. Our services including almost all types of healthcare product registration,clinical trial approvals, approvals for marketing authorization, ethics committee approvals and permits to import products.
“He who studies medicine without books sails an uncharted sea, but he who studies medicine without patients does not go to sea at all.”
Products for Regulatory Support
We provide regulatory expertise for the products including pharmaceuticals & biologics, nutraceuticals& supplements, cosmetics, and medical devices.
- Pharmaceuticals & biologics – Pharmaceuticals, biological products, vaccines and other drugs that are the treatment and preventive solutions.
- Nutraceuticals & supplements – Dietary supplements,fortified dairy products, antioxidants, vitamins & minerals, cosmetics or complementary medicines that form a large amount of healthcare products in the market.
- Medical devices – Physical devices, implants,all types of supporting devices and software that are the most common medical devices.
Our Services
- Providing services for clinical study in Asian countries (Korea, China, Japan, India and Taiwan etc).
- Product Development proposals.
- Preparation, coordination and supervisionof regulatory documents submissions.
- Minimization of service time by coordinating with Food and Drug regulatory departments of Asian countries about the issues involved in all stages of theclinical study, product registration, marketing authorization submission process.
- Review of product quality,conformance and assurance ofregulatory compliance.
- Registration of products following the guidelines and regulations of Food and Drug regulatory departments of Asian countries.
- Providing services according to current regulations in practice
- Search of patent status of pharmaceutical products and trademark.
- Consultation to the pharmaceutical companieson market search in Asian countries.
How we work
We have been continuously striving to create better and easily accessed healthcare system across world and as a responsible corporate entity, we strongly support to use the eco-friendly products.
