Advanced Therapy Medicinal Products (ATMP)

Advanced Therapy Medicinal Products (ATMP) von HORN Pharmaceutical Consulting

Von: HORN Pharmaceutical Consulting  08.07.2009
Keywords: Consulting, advanced therapy industry, Biotech products,

 HORN Pharmaceutical Consulting provides ATMP manufacturers with all necessary requirements and guidelines in order to meet the criteria of CAT (Committee for Advanced Therapies within EMEA). We help you achieve successful global product development no matter your size, phase, development need or goal. Our know - how is the result of many years of experience with somatic cell therapy products, gene therapy products, tissue engineering products etc.

  We guarantee that we will understand Your needs and offer You exemplary quality. Our specifically tailored solutions that fit your products, needs and goals include: 
        Preparation of project plans and regulatory strategies from early phases of drug development to submission of regulatory dossiers 
        Design the best strategies for optimization of regulatory compliance of ATMPs 
        Guidance and advice to project teams
        Coordination and control of projects 
        Preparation, review and submission of Investigational Medicinal Product Dossier (IMPD) documents and Clinical Trials Applications (CTA) for submission of clinical trials 
        Preparation and review of Investigator's Brochures, Study Protocols, Study Reports
        Interaction with study management 
        Interaction with contract manufacturers and contract laboratories 
        Preparation, review and submission of Common Technical Document (CTD) for Marketing Authorisation Application (MAA) 
        Preparation of meeting packages for Authority meetings
        Conduct of Authority meetings and preparation of follow-up activities 
        GMP compliance covering the product specific needs for state of the art manufacture of investigational new drugs 
        Preparation of potential regulatory agency inspections (GCP)

Keywords: advanced therapy industry, Biotech products, Consulting, CTA (Clinical Trial Application), IMPD, MAA (Marketing Authorisation Application), Regulatory Authorities,

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