Regulatory Affairs

Regulatory Affairs von HORN Pharmaceutical Consulting

Von: HORN Pharmaceutical Consulting  08.07.2009
Keywords: Projektmanagement, Consulting, Horn

HORN services ensure enough flexibility to deal with the unexpected. 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.  

We are offering help in all aspects of regulatory affairs, such as:
·         Quality / Chemistry, Manufacturing and Controls (CMC)
·         Non-clinical development
·         Clinical development

Our Experts
We are stuffed by a team of passionate and experiences specialists in the planning and preparation of regulatory documents. Our experts can save you valuable time and money by assisting you with the fulfilment of the international regulatory requirements. 
You will receive local and global scale assistance with the development of your product.We can prepare validation master plans that are comprehensive and in full compliance with all regulatory requirements (US, EU and national). Furthermore, we have extensive experience in the establishment of documentation standards and in the validation of biopharmaceutical facilities, equipment, and processes.  
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.

Services
Our customized services include:
·         Development of regulatory strategies
·         Preparation of development plans
·         Interaction with regulatory Authorities
·         Preparation and conduct of meetings with Authorities
          o        In Europe: scientific advice meeting, protocol assistance meeting, pre-submission meeting  
          o        In US: pre-IND-meeting, end of phase II meeting, pre-submission meeting, advisory committee   meeting, scientific meetings
·         Efficient preparation of meeting packages (national, EMEA, 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

Keywords: Biotech products, Clinical Development, Consulting, CTA (Clinical Trial Application), Horn, IMPD, IND (Investigational New Drug Application), MAA (Marketing Authorisation Application), medical device industry, NDA (New Drug Application)/ BLA (Biologic License Application), Non-clinical Development, Projektmanagement, Regulatory Affairs, Regulatory Authorities, SME (Small and Medium-sized Enterprise),

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