Regulatory Affairs

Different regulatory requirements present a challenge to continuous improvement and technical innovation. In this world of constantly changing regulations, it is important to find a reliable partner in the management of regulatory issues.

At HORN Pharmaceutical Consulting we know that it is vital for you to keep you abreast of the rapidly developing regulations. Our specialists can save you valuable time and money by assisting you with the fulfillment of the international regulatory requirements. You will receive local and global scale assistance with the development of your product. We support you to establish efficient collaboration with Authorities through providing proactive, customized high quality solutions. To achieve it, we align and integrate our experience within our customers' operations and provide solutions specifically tailored to their needs. Our knowledge of scientific, legal and business issues will help you to handle your product from early stage of development, through the entire regulatory process, to a successful marketing authorisation.

HORN services ensure enough flexibility to deal with the unexpected. We are offering help in all aspects of regulatory affairs, such as:

Services

Our customized services include:
  • Development of regulatory strategies
  • Preparation of development plans
  • Interaction with regulatory Authorities
  • Preparation and conduct of meetings with Authorities
    • In Europe: scientific advice meeting, protocol assistance meeting, pre-submission meeting
    • In US: pre-IND-meeting, end of phase II meeting, pre-submission meeting, advisory committee meeting, scientific meetings
  • Efficient preparation of meeting packages (national, EMA, FDA)
  • Project planning for regulatory activities through all phases of drug development
  • Preparation and review of Module 1 CTD documents (e.g. application form, proposed product information and drug labelling)
  • Preparation, review and submission of regulatory documents in EU and US (IMPD/IND) and CTD documents
  • Evaluation of technical data prior to submission (quality, clinical and non-clinical documents)
  • Management of follow - up activities after submission
    • Variations and changes
    • Renewals
  • Preparation and submission of orphan drug applications
  • Small business assistance programs /Support for SMEs (Small and Medium-sized Enterprises)
  • General and in-house regulatory affairs training

HOTLINE

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

Events

  • 08.05.2019
    Mannheim: Aktuelle Trends in der Qualitätskontrolle
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  • 14.-15.04.2019
    Cologne: Der Regulatory Affairs Manager
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  • 16.-17.05.2019
    Vienna: Annex 2 & Co - GMP Compliance for Biopharmaceuticals
    More
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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
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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