The industry is facing new expectations and requirements due to the constantly changing environment in the Chemistry, Manufacturing and Controls (CMC) area, accompanied by fast evolving new technologies. Supply chain strategies, including different suppliers, contract manufacturers and analytical contract laboratories might be of interest for you, even if they add more complexity to the process. HORN Pharmaceutical Consulting will take care of your needs and guide you through this process. We will advice you on the best strategies to use throughout your process.
In order to receive a new marketing authorization by the regulatory Authorities, the CMC part of your submission (CTD) should contain adequate information about the drug substance and the drug product. From early clinical trials to submission, drug substances and drug products are further developed and more CMC-information is gathered. Regulatory requirements acknowledge this difference in spelling out detailed guidance for IMPD/IND-documents as well as MAA/NDA-documents. We know how important it is to differentiate between GMP and regulatory documents. We are the CMC-experts and guide you through the decision making process. We tell you which the level of detail to include within your regulatory documents. These decisions are important for you with respect to changes which will always be introduced during development and even after registration. Please bear in mind that you can avoid costs and compliance risks, if you consider this for the preparation of your dossiers.
With our detailed knowledge of CMC-requirements combined with long-term practical experience, we will show you what needs to be done and how to do it most efficiently. We will make you aware of the risks you take and will show you the way to successful marketing authorization.
We have experts specialized in various kinds of drug substances and formulations, ranging from small molecules and peptides, to biological and biotechnology derived products (e.g. antibodies, proteins, vaccines, etc.). We furthermore support you with experience and know-how in the area of advanced therapies, such as biotissues and somatic cell therapies. With our experience gained in the past on these specific products we help you to speed-up your product development and help you to identify what is really needed.
We can help you to define the right CMC strategy from the beginning of your product development throughout the product’s life cycle. We know the specific differences of EU- and US-dossiers and have long term experience in preparing global dossiers. This way we can help you to find the most efficient way in preparing your dossier for submission in various countries all over the world. We will also guide you through the complex process of gathering CMC-data from all your suppliers, contract manufacturers or analytical laboratories, and will show you how to plan effectively this process.
Our CMC-services include, but are not limited to the following activities:
Design the best strategies for preparation and submission of global dossiers
Preparation, review and submission of CMC-documents
Preparation and review of CMC-data for
Investigational Medicinal Product Dossiers (IMPD)
Common Technical Document (CTD): Module 2.3 (Quality Overall Summary) and Module 3 (Quality) for European Marketing Application Authorizations (MAA)
Certificates of suitability to the monographs of the European Pharmacopoeia (CEP)
Active Substance Master Files (ASMF)
Preparation and review of CMC-data for
Investigational New Drug Applications (IND)
Common Technical Document (CTD): Module 2.3 (Quality Overall Summary) and Module 3 (Quality) for New Drug Applications (NDA) and Biologic License Applications (BLA)
Drug Master Files (DMF)
Preparation, review and submission of variations in Europe and post-approval changes in US
Interaction with contract manufacturers and contract laboratories
Preparation of meeting packages for Authority meetings (FDA, EMA, national)
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HORN Pharmaceutical Consulting
CMC – GMP – Regulatory Affairs
Dr. Hiltrud Horn
Am Alten Schloß 1
Phone: +49 (0) 7251/305 527
Fax: +49 (0) 7251/305 528
Mobile: +49 (0) 160/5834 213
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+49 (0) 7251/305 529
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25. - 27.10.2016
Berlin: Product Transfer - Organisation of GMP-compliant Site Change
27. - 28.10.2016
Barcelona: Drug Master File Procedures in the EU, the US and Japan
Bonn: Wirkstoffe/APIs - Regulatory Affairs Know-how
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News for the Industry
News on Change Control/Variations:
EU: Revised GMP-Annex 2 published - Details defined for biological products including ATMPs
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