CMC Expertise Accelerating Biologics Development for 20 Years and Counting

Working with my co-founders, colleagues, and clients on many fascinating projects over the last twenty years has been an honor. From the founding of the firm with former Pfizer colleagues until today, we have specialized in supporting the CMC and regulatory programs...

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




CMC Strategy

Quality Assurance

Analytical Services

Regulatory Consulting & Submissions Support

Process Development & Validation

Contract Services & Tech Transfer Support

Supply Chain Management

Inspection Readiness

Project 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.


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.