Regulatory Intelligence

Regulatory intelligence focuses on the essentials in the regulatory world and keeps you abreast of what you really need to know for your development product.

If you want to know what is going on in the regulatory world and if you want to save time and money in avoiding regulatory pitfalls you should look in detail into the regulatory environment. Knowing which products are in development, which products are successful and which products were approved is important for your own drug development. Evaluating the risks of your product, knowing why others failed, or were approved later than expected, might also be of specific interest for you as you might like to think about potential regulatory hurdles early on and set up your development program accordingly.

Knowledge of new regulatory requirements, specific regulatory trends and interpretation of global regulatory requirements is of utmost importance for your development. Ensuring compliance means meeting regulatory expectations and considering them adequately in all phases of drug development.

There are many tools available where you can readily find information about regulatory requirements, about products in clinical trials and about approval of products. However, the process of finding, reading and extracting the essential information is extremely time-consuming.

Knowing these facts is of utmost importance for your development products, since you need to define the right strategies early on. You need to consider current guidelines, future regulatory trends and you also need to take the right decisions on how to adhere to those for your specific drug product. Therefore, the right interpretation of regulatory guidance documents is one of the key-factors to success.

HORN Pharmaceutical Consulting will show you how powerful knowledge can be. We will allow you to avoid time-consuming searches of the internet in providing you specifically tailored information covering your needs.

Services

Our specifically tailored services include:
  • Evaluation of regulatory guidelines
  • Information about regulatory trends
  • Interpretation of regulatory guidelines for your specific product
  • Information about products in development
  • Information about approved products
  • Product development strategy
  • Analysis of regulatory challenges and marketing opportunities
  • Review of competitors
  • Information about inspections

HOTLINE

Phone +49 (0) 7251/305 529
Fax +49 (0) 7251/305 528
Mail

Events

  • 29.-30.10.2019
    Hamburg: How to provide process validation data in regulatory submission
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  • 13.-14.11.2019
    Mannheim: Projektmanagement in Regulatory Affairs
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  • 19.11.2019
    Brugg: MEGRA StartUp
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News

  • 10.03.2017
    News for the Industry
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  • 26.07.2013
    News on Change Control/Variations:
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  • 31.01.2013
    EU: Revised GMP-Annex 2 published - Details defined for biological products including ATMPs
    More
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EU: New Variation System in force as of Jan 1, 2010. Filing of variations will be faster, easier, and more flexible. Have you considered that your Change Control System needs to be updated accordingly?
EU: Centralised Marketing Authorisation Procedure for ATMPs needed Have you already filed your application? The time clock is ticking. Transitional periods will be over soon.
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