Accelerate your path to market
The leading authority on CMC and regulatory consulting for biologics, cell, and gene therapies.
Our expert biologics, cell, and gene therapy consultants augment and optimize your technical team helping you to succeed within often unchartered territory.
Years of Experience
Regulatory Consulting & Submissions Support
Process Development & Validation
Contract Services & Tech Transfer Support
Supply Chain Management
Gene Therapy CMC Strategies Paving the Way for Commercialization
This paper offers both background and a look to the future as gene therapies continue to make an incredible impact on the therapeutic landscape including a great deal of promise on the horizon.
The Evolution of Therapeutic Monoclonal Antibodies (mAbs)
This paper explores some of the exciting directions mAb therapy is heading, and the challenges and enabling technologies impacting this therapeutic area.
EU’s Drug Device Combination Product Regulatory Changes
Manufacturers and developers submitting drug–device combination (DDC) products for market approval on or after 5/26/20, must comply with the new regulations.
Biologics and Gene and Cell Therapy Consulting
Quickly and successfully augment and optimize your technical, manufacturing, analytical, and regulatory resources with services from BioTechLogic.
Our success lies in serving as technical experts and guides while 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.
E B O O K
Designing a Gene Therapy CMC Architecture for the Full Product Lifecycle
Process Development & Contract Services Decision Making
This guide helps give gene therapy innovators a high-level perspective on the process development and contract services selection decisions to be made throughout the phases of development.