Project Management

Successful application for marketing approval requires a comprehensive strategic approach. At HORN Pharmaceutical Consulting, our broad project management experience enables us to develop the best strategy for your drug development and submission of your application to Authorities. Efficient project management will help you to reach your goals as planned and to maximize your chances of success.

HORN Pharmaceutical Consulting - Plans Your Success!

Guided by the old proverb "Failing to plan is planning to fail", our project managers guarantee that all concepts of your project are planned in details, discussed with you and efficiently implemented. Our project managers will make sure that the goals and objectives of your project are met on time, within budget and with the highest quality. In order to keep track, we will provide you with regularly update reports.

However, simply having a rigid strategy is not enough for success. The modern environment of constant change requires agility. At HORN Pharmaceutical Consulting we provide you with enhanced flexible solutions for your project. We proved that we can manage time critical projects successfully and in time. We think proactively and plan for your success. We also tell you early on about the risks of your project, how to avoid regulatory or compliance issues and how to cope with the unexpected. This way you avoid pitfalls which would cause delays in your submission process. We tell you how to develop the right strategies and how to reach your goals on time.


Our professionals are committed to providing the following customer services:
  • Preparation of project plans from early phases of drug development to submission of regulatory dossiers
  • Guidance and advice to project teams
  • Definition of regulatory strategies for drugs in development and marketed products
  • Communication with Authorities
  • Preparation and conduct of meetings with Authorities (EMA, FDA, national)
  • Preparation of project status reports
  • Coordination and control of projects


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


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


  • 10.03.2017
    News for the Industry
  • 26.07.2013
    News on Change Control/Variations:
  • 31.01.2013
    EU: Revised GMP-Annex 2 published - Details defined for biological products including ATMPs
Get all news
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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