Biotissues / Cellular Products
Biotissues / Cellular Products
In the last decade new types of pharmaceutical products were developed. These preparations differ from commonly known pharmaceuticals, as the active substance is not derived from classical chemical synthesis or biotechnological production techniques.
Advanced Therapy Medicinal Products (ATMPs) are based on mainly human cells as essential component or as precursor of the active substance. By using such cell based products, novel targeting strategies could be developed, such as immunotherapeutic products for the treatment of cancer. Therefore, advanced therapies cover the gap between biotechnological preparations, such as insulin, and medical devices, such as implants and include gene therapy, cell therapy and tissue engineering products.
The legislative and regulatory frameworks for such pharmaceutical preparations are under constant development. These regulations serve in the patient’s safety interest as basis for high quality preparations, but reflect also a huge challenge for regulatory compliance for manufacturers of advanced therapy medicinal products.
HORN Pharmaceutical Consulting will help you to optimize your manufacturing process and to set up your control procedures in line with the latest regulations. With our professional assistance, you will successfully set up your development program.
You can benefit from our experience in this field gained over many years on various projects (cellular products, bio-tissues). We are the ATMP-experts and will guide you through the development of your advanced therapy medicinal product. We can tell you how to proceed considering the fast evolving regulations. Take the chance to benefit from our know-how. We tell you how to proceed efficiently in an international environment with different regulatory requirements. Your product is unique and requires specific expertise which we can offer. With us you will understand what is important to do prior to starting your clinical trial and what to consider for the registration of your product. We will also guide you through the preparatory activities for passing authority inspections, and will show you how to avoid compliance risks and delays in the approval process.
Our customized services include:
Preparation, review and submission of IMPD-documents for submission of clinical trials
Design the best strategies for optimization of regulatory compliance of ATMPs
Interaction with contract manufacturers and contract laboratories
Preparation of meeting packages for Authority meetings
Conduct of Authority meetings and preparation of follow-up activities
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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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News on Change Control/Variations:
EU: Revised GMP-Annex 2 published - Details defined for biological products including ATMPs
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