Our Experience

HDR COMPANY LLC is the recognized as leader in biologics CMC consulting on technical, business, and strategic matters. We have helped clients bring their product candidates from research into clinical trials and have provided expertise in the commercialization of more than 10 different licensed biologic products. 

CLIENTS
The Company has served hundreds of clients for projects ranging from early stage discovery research through development and commercialization. We value our client relationships and are pleased to continue to work with many of our original clients.

Our clients include:

• Pharmaceutical companies
• Start-up biotechnology companies
• Virtual companies
• Development organizations
• Large and multi-national companies
• Discovery companies with no development expertise
• Investment banks and venture capitalists
• Professional organizations
• Vendor and service companies

Technologies and Services
Our technical, operational, quality, and regulatory experience ranges from expert technical input on specific issues to oversight and management of entire manufacturing development programs; and from bulk drug production from a recombinant host to labeling and distribution to the clinical trial sites. We have written multiple regulatory submissions, including INDs, BLAs, MAs, and others.

We have had extensive experience with technologies and products that include: 

• Antibodies
• Recombinant proteins
• Peptides- natural and synthetic
• Oligonucleotides
• Cell and Gene and therapy (ATMPs)
• Conjugates
• Natural products
• Vaccines