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Liquent Regulatory Solutions for Life Sciences

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IDRAC Database: Who Benefits?

Subscribers who currently benefit from the power of the IDRAC database include pharmaceutical companies, biotechs, CROs, RA associations/universities and many more.

In fact, over 150 small, medium and large companies across the globe are already using IDRAC. That amounts to IDRAC database installations in over 500 individual sites, comprising over 30 countries!

Within these companies, the following departments use IDRAC:

  • Registration/Regulatory Affairs
  • Clinical
  • Quality Assurance
  • Manufacturing
  • Marketing
  • Legal Services
  • Pharmacovigilance

How do I specifically benefit from using IDRAC?

Think about all the challenges that you and your organization face just today:

  • How do I deal with renewals and variations?
  • What are the pharmacovigilance reporting requirements for an ADR in 25 countries?
  • How should I deal with an FDA inspection?
  • How should I notify the authorities before starting clinical trials?
  • What are the latest Federal Register announcements affecting adverse experience reporting and how do they fit in with the CFR?

IDRAC anticipates your needs by preparing and maintaining up-to-date answers to these and similar questions that cover the entire drug development lifecycle.

As a result, the people in your company currently involved in the collection, filing, archiving and retrieval of regulatory intelligence can focus their efforts on more mission-critical activities. Through IDRAC, Liquent checks, updates, compiles and treats relevant information; in short, we do all the desk research so that regulatory professionals have more time to concentrate on regulatory strategy.

Scenarios

As a small biotech company, you've partnered with a big pharma company to complete the development of your product and get it registered. IDRAC empowers you with the knowledge you need to ensure that your partner is pursuing the optimal regulatory strategy, whether it is Japan, Europe or the United States.

As a small biotech company, you've licensed your star product to Japanese and European partners for development in those countries. IDRAC enables you to keep a close eye on progress the licensees are making.

IDRAC subscribers do not need a multinational team, because IDRAC is already covering most of the world!