Customized solutions

With one standard, LEVA Pharmaceutical seeks different solutions for various new drugs to tap into the market.

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Business introduction

Equivalence Assessment

The generic drug equivalence assessment is not the application for new drug R&D registration, but re-assessment work of already marketed drug. It has its special process and research content, mainly including equivalence assessments of quality (pharmacy research) and efficacy (clinical research BE).

LEVA Pharmaceutical has signed exclusive cooperation agreements with more than 10 record bases to support rapid implementation of project and customize research environment.

Experience in multiple fields: gastroenterology, cardiology, oncology, psychiatry, endocrinology, respiratory, etc.

Expert team: a strong team made up of experts of pharmacy and clinical research.

Customized clinical protocol: providing featured options to ensure the scientific rigor of protocol and reduce investment and time.

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Business introduction

Phase 0 Service

LEVA Pharmaceutical is the first CRO company in China that performs Phase 0 drug clinical trials, which has worked  with Beijing Shijitan Hospital to implement the first domestic phase 0 clinical trial.
What is a phase 0: it refers to collecting data of drug safety and pharmacokinetic tests through limited size and population before the new drug starts phase I clinical trial, in order to provide decision-making basis for new drug R&D.
Confusions in Phase I~IV clinical trials 
● Unpredictable drug toxicity makes 75% R&D investment wasted in early clinical phases.
● Unable to accurately speculate the starting dose of a drug used in the human body for clinical trials, making around 40% drugs eliminated at Phase I clinical trial.
● Difficult to use animal experiments to accurately predict pharmacokinetic and toxicological data in human body, causing effective compounds eliminated wrongly.

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Business introduction

Customized solutions

Purpose-oriented to interpret your demands more accurately

In combination of thorough analysis on your demands and our deep understanding of the standards, we extract the key and difficult points of the project and provide reliable support for the follow-up protocol design.

Common goal; customized project solutions

We plan better ways for realizing your demands, customize reasonable project solutions to perform time, money, and risk control, and provide reliable research services.

With concentration making us more professional, we know all about the standards

Professional talents, with rich practice experience, have senior industry background and rich resources, and they are proficient in the policies and regulations of all links.Good communication channels, and fully understanding all key points of relevant policies.

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contact us

address:

12th Floor, Zhonghai Building, Shijingshan District, Beijing

telphone:

8610-88255958/88255598

Fax:

e-mail:

market@levacro.com

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