InnoStar's Global Application Assistance

With an in-depth understanding of applicable regulations, policies and technical requirements for drug applications, InnoStar's experts provide a wide range of consulting services, including Investigational New Drug (IND) Applications, New Drug Applications (NDAs), Abbreviated New Drug Applications (ANDAs) for submissions to Chinese NMPA; IND Applications, NDAs/BLAs and ANDAs to the US FDA; Clinical Trial Applications (CTAs), Marketing Authorization Applications (MAAs), Drug Master Files (DMFs) and generic drug applications in the EU, etc. At the same time, InnoStar provides writing services for Sections 2.4 and 2.6 within the applications and nonclinical pharmacology and toxicology summaries to facilitate the process. The number of applications that are submitted, reviewed and approved with the assistance of InnoStar is growing rapidly, covering various types of drugs, targets and therapies, particularly in the field of innovative drugs and first-in-class drugs domestically and internationally.

Digital Data Collection and Reporting System

Provantis

InnoStar uses the Provantis system to collect toxicology data, enabling data analysis and sharing at all stages from receipt of the test article to issuance of the final report. In this system, the integrated general toxicology module allows the flexibility required for modern study designs, supports toxicology studies with different species, durations of drug administration, and administration routes, manages clinical pathology testing instruments, handles sample requests and processes relevant results and data. The reproductive toxicology module supports different reproductive toxicology studies, including ICH standard studies, toxicokinetics and evaluation of developmental toxicity and behavioral and developmental neurotoxicity.

SEND Data

On December 17, 2017, the FDA SEND 3.0 Mandate for providing regulatory submissions in electronic format came into force. All organizations must use the appropriate FDA- supported standards, formats and terminologies specified in the FDA Data Standards Catalog for IND, NDA, ANDA and certain BLA submissions. In addition, the requirement later widened the scope to include safety pharmacology and reproductive toxicology studies. InnoStar introduced the Submit platform solutions from Instem, which cover the whole set of workflows, including tools and professional services to support the creation and management of datasets, and seamlessly accept data from the Provantis system to enable the flow of SEND data into a data repository and onwards to be submitted to the regulatory agencies as required. By the end of 2022, we have gained rich experience after completing 140+ projects.

Our Advantages

By the end of December 2022, InnoStar has served more than 640 pharmaceutical companies, new drug R&D institutions and research institutes in China and foreign countries. We have completed more than 10,000 clinical and nonclinical studies, including more than 2,700 nonclinical studies following international guidelines and more than 950 nonclinical evaluation projects for innovative drugs (covering pharmacokinetics and safety evaluation), and have assisted with 14 successful NDAs/BLAs and more than 270 successful IND applications in China and more than 60 IND applications with innovative drugs approved by foreign regulatory agencies in the US, EU, South Korea, Australia and other countries.