Regulatory Support in Asia-Pacific
With a diverse culture and varying degree of regulations, regulatory support in Asia-Pacific region focusses on country-specific requirements as well as a regional marketing focus. Credevo offers a particular home advantage in Asia-Pacific having a key understanding and local expertise in regulatory affairs for almost all major countries in the region.
Not only the pharmaceuticals, and biologics, Asia-Pacific region provides excellent opportunities as well as regulatory challenges for nutraceuticals, and medical devices as well. Facilitate healthcare product registration, marketing authorization approvals, clinical trial approvals, ethics committee approvals and import permits in this region with Credevo.
Utilize local regulatory expertise in various countries for your products with Credevo’s home expert advantage!
Products For Regulatory Support in Asia-Pacific
| Drugs & Biologics |
| Asia-Pacific presents a strong case to utilize expert regulatory support for pharmaceuticals, biological products, vaccines and other drugs’ regulatory requirements. |
| Nutraceuticals, & Supplements |
| Some of the fastest growing markets for dietary supplements, nutraceuticals, cosmetics or complementary medicines are in Asia-Pacific region. Process to register varies in each country. |
| Medical Devices |
| Physical devices, supporting devices and software are some of the most common medical devices used worldwide. With different ways to use them, their marketing authorization process may vary a lot. |
Types of Regulatory Support Available
| Regulatory Applications |
| A well prepared application is the key to a successful regulatory submission. |
| Specific information |
| Before preparing an application, you may need specific information or answers to important questions. |
| Feasibility Assessment |
| An assessment of regulatory requirements & feasibility can save a lot of time & cost in achieving a successful regulatory approval. |
Get help on these regulatory support needs here
Regulatory requirements vary across countries and product segments.
For all of these needs, Credevo provides support extending from advisory & consultancy support to end-to-end regulatory support for product registrations as well as clinical trial related approvals.
Country – Specific Regulatory Support
Asia-pacific region is a big group of countries with diverse regulatory requirements. This results in a need of detailed understanding of regulatory requirements for various healthcare products. Connect with Credevo to discuss regulatory requirements in various countries in this region.
Australia
China
Hong Kong
India
Indonesia
Japan
Malaysia
New Zealand
Philippines
Singapore
S. Korea
Taiwan
Thailand
Vietnam
Rare Diseases Regulatory Support
Credevo offers special services in rare disease drug registration with a complete understanding of various benefits and incentives provided by the regulators in the Japan, Australia and other Asian countries
Learn more on Registration & FDA Support For Orphan Drugs in Rare Diseases
Learn more on various benefits and incentives provided by regulators in the
The final goal of any healthcare organization is to place their product into market at the earliest. However, the pathway to get a product onto the market can be challenging.
Credevo has well-established infrastructure and expertise to provide regulatory support globally for marketing authorizations and life cycle management (LCM) of various pharmaceutical products, generic drugs, nutraceuticals, medical devices and Biosimilars.
Connect with us to explore our services
Mail your queries at helpdesk@credevo.com or contact us in other ways.
Clinical Development Strategy | Clinical Trial Feasibility | Rare Disease Services | Global Clinical Operations