ABOUT BIOTECHLOGIC
We are a biopharmaceutical manufacturing and CMC biologics consulting firm to successfully augment and optimize your technical team.
Our experience is diverse including a wide range of biological, oligonucleotide, gene, and cell therapy products.
Gene Therapy CMC Strategies Paving the Way for Commercialization
Earlier days of gene therapy development, and the sometimes dashed hopes of both developers and regulators, taught us that very early-phase product understanding and characterization is critical.
Navigating the EU's Drug Device Combination Product Regulatory Changes
Regulation (EU) 2017/745 was enacted into law on May 25, 2017, are is scheduled to go into effect of May 26, 2020. The paper explores the changes in this new regulation will bring and areas to think about to make sure you are prepared.
The Evolution of Therapeutic Monoclonal Antibodies (mAbs)
Earlier days of gene therapy development, and the sometimes dashed hopes of both developers and regulators, taught us that very early-phase product understanding and characterization is critical.
Biopharmaceutical Consulting Services
Quickly and successfully augment and optimize your technical, manufacturing, analytical, and regulatory resources with services from BioTechLogic.
Our success is due to our ability to serve as the technical expert and consultant, while also functioning as a hands-on resource that successfully drives and executes your plan.
We define the path, focus the resources, and drive the process to meet every milestone. Services from BioTechLogic can be reviewed using the menu on the right.
Contact Us
BioTechLogic, Inc., is a biopharmaceutical manufacturing and CMC consulting firm with strategic and practical/hands-on experience that helps clients bring their products to market quickly and successfully by augmenting and optimizing an organization’s technical, manufacturing, analytical, and regulatory resources.
P.O. Box 7230, Cave Creek, AZ 85327
For service-related questions
Tracy TreDenick: ttredenick@biotechlogic.com
Peter Dellva: pdellva@biotechlogic.com