Dear Customers,

At Kalnin Consulting LLC, we are dedicated to providing exceptional expertise in operations leadership. If you are in search of a highly motivated and skilled partner to guide all aspects of Research and Development (R&D), your search ends here.

With over 25 years of proven leadership success in vaccine and drug development, our founder, Kirill V. Kalnin, PhD, offers extensive experience and deep technical expertise in infectious diseases. His esteemed portfolio includes recognized contributions to vaccines for Anthrax, Clostridium diff, Chlamydia, HRV, RSV, Flu, HPV, Lassa, Chikungunya and COVID, employing both protein and mRNA technologies (including sa and nsa formats). At Kalnin Consulting, we take pride in our proactive approach and unwavering commitment to continuous improvement. Our team excels at identifying inefficiencies and revitalizing underperforming operations, ensuring substantial value for your organization.

Here are some of the key services we offer:

- Strategic Planning & Execution

• Defining and(or) evaluating the Target Product Profile (TPP)

• Project Plan development in alignment with TPP

• Resource allocation both internally and externally

• Comprehensive Customer Support throughout all stages: from preclinical proof of concept to IND/BLA submission

- Management of Product Development

• Drug Substance/Product Development

• Process Development (Upstream/Downstream)

• Chemistry, Manufacturing and Control (CMC)

• Quality Assurance/Control (QA/QC)

• xGMP Manufacturing

-Data Analytics & Reporting, including tailoring IND/BLA submissions

We invite you to partner with us and discover how our hands-on leadership style, coupled with extensive experience, can positively impact your organization's vision and objectives, accelerating the progression of your products to the clinic.

Thank you for considering Kalnin Consulting as your trusted advisor. We look forward to the opportunity to work together and help you achieve your goals.

Sincerely,  
Kirill Kalnin, Ph.D.
Founder and President