Credevo is a globally connected organization providing its expertise to pharma industries regardless of size and sector in all aspects of regulatory affairs
Our services extend from advice to full-range support, product registration service – right from dossier preparation and compilation to submissions with regulators worldwide, providing knowledge based advice for the best and most efficient regulatory pathway selection.
Marketing authorization of medicinal products
The final goal of any pharmaceutical organization is to place the drug into the market at the earliest and 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.
Credevo offers special services in rare disease drug registration with a complete understanding of various benefits and incentives provided by the regulators in the united states, Europe, Japan, Australia and in Asian countries
Nutraceutical and Complementary medicines regulatory
Regulatory for medicinal products or pharmaceuticals is different from neutraceuticals or complementary medicines. Various regulators have predefined regulatory for marketing approval
Credevo has its expertise in getting approvals with various regulators around the world with sound knowledge of requirement and pathways to provide efficient and fast approvals
Rare Disease Services
Rare disease drug development is often challenging right from discovery to market approval as these drugs or medical devices are to be used by very few patients.
Credevo offers expertise in understanding the regulatory process and benefits provided by regulators and reduces the burden on the rare disease drug developers
Clinical trial applications
The clinical trial application process can be complex and can cost your organization significant time and money along with sound regulatory understanding
Credevo provides expertise for all aspects of Clinical Trial Applications (CTA) and Investigational New Drug (IND) applications with sound knowledge and experience in working clinical regulators around the world
To learn more on the Clinical Trial Application (CTA) approval process & Regulatory in various regions click on the country below
- North America – The United States, Canada
- Asia – China, Japan
- Pacific – Australia, New Zealand
Medical device regulatory
Rapid regulatory amendments are one of the most troublesome challenges for medical device companies in seeking approval of a new product. Another complication in medical devices is the regulations differ with several categories of medical devices
Credevo understands every regulatory requirement in-depth to provide flawless approval to medicals devices with good in-depth understating of various regulatory approaches. Credevo also processes special approvals such as Device 510(k), CE marking, etc.
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