HORN Pharmaceutical Consulting
Consulting, Training, Horn
The industry is facing new expectations and requirements due to the constantly changing environment in the Chemistry, Manufacturing and Controls (CMC) area. HORN Pharmaceutical Consulting can help you cope with the global jungle, no matter whether your product is in the pre-clinical, clinical or marketing phase.
Supply chain strategies, including different suppliers, contract manufacturers and analytical contract laboratories might be of interest for you. We will advice you on the best strategies for your individual needs and guide you through this process. The CMC part of your submission should contain adequate information about the drug substance and the drug product at each stage of development. Regulatory requirements acknowledge this difference in spelling out detailed guidance for IMPD/IND-documents as well as MAA/NDA-documents.
Why HORN Pharmaceutical Consulting ?
· We can help you to define the right CMC strategy from the beginning of your product development throughout the product’s life cycle in a global market
· We provide 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 · We know how important it is to differentiate between GMP and regulatory documents.
· We guide you through the decision making process on the level of detail to include in your regulatory documents
· We provide you with information on the potential consequences with respect to changes being introduced during development and even after registration
· 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.
, IND (Investigational New Drug Application)
, Regulatory Authorities