Navigate Your Way Towards Biopharmaceutical Success With Us

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Welcome to Bob Sullivan CMC Consulting, where expertise meets excellence. Founded by Robert Sullivan, PhD, our consultancy is dedicated to delivering top-tier services in the biopharmaceutical field. With over 25 years of industry experience, Dr. Sullivan is the driving force behind our consultancy, serving as our Principal Consultant and Founder.


Our commitment to excellence is underpinned by a deep understanding and a broad perspective in the biopharmaceutical sector. We specialize in both NCEs (New Chemical Entities) and Generics, and we've had the privilege of working with a spectrum of companies, ranging from small startups to large industry leaders. This diversity of experience has equipped us with a unique and comprehensive viewpoint, ensuring we're well-prepared to tackle the most complex challenges.


At Bob Sullivan CMC Consulting, we pride ourselves on our ability to provide in-depth knowledge and strategic insights into all aspects of drug substance and drug product CMC (Chemistry, Manufacturing, and Controls) development. Our expertise covers every facet, from formulation and analytical development to process development, tech transfer, manufacturing, validation, and quality control.


We understand the pivotal role that CMC development plays in the life cycle of pharmaceutical products, especially in the context of IND (Investigational New Drug)-enabling studies. As a trusted partner, we're committed to guiding you through the intricate processes and regulations that govern this critical phase of drug development.


Our mission is to facilitate your journey, ensuring that your biopharmaceutical endeavors are marked by precision, quality, and compliance. At Bob Sullivan CMC Consulting, we're not just a consultancy; we're a driving force dedicated to your success. When you choose us, you choose experience, innovation, and the promise of a mastery for your pharmaceutical products.


If you have questions or would like to explore how we can assist you in your pharmaceutical endeavors, please feel free to reach out. You can contact us via phone at 1.858.218.6224 or by email at bob@bobsullivancmc.com. Alternatively, you can use the convenient online form to get in touch with us.

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End to End CMC Services


As CMC consultants, Hughes Sullivan Biopharma brings over 25 years of industry expertise to our clients in the biopharmaceutical filed.  Our experience spans NCE’s and Generics in small to large companies providing us with a diverse and comprehensive perspective. 


We offer in-depth knowledge and strategic insights into drug substance and drug product CMC development and IND-enabling studies, including formulation, analytical and process development, and tech transfer, manufacturing, validation, and quality control.

biopharmaceutical consult

Development

GMP Manufacturing

Stability

Regulatory Strategy

Regulatory Filing

Registration

Validation

Commercialization

Small Molecule

Protac

Peptide 

Oligonucleotide

Peptide-Oligonucleotide Conjugates


Formulation Development

GMP Manufacturing

Stability

Regulatory Strategy

Regulatory Filing

Registration

Validation

Commercialization

Tablets 

Extended-Release Tablet

Capsules

Extended-Release Capsules

Injectables

Highly Viscous Injectables

Emulsions

Lyophilization

Method Development

Phase-specific Validation

Specification Development

Control Strategy

Stability Studies

Compatibility Studies

Extractables/Leachables

Characterization

Quality Control

Comparability Studies

Studies for Oncology

Studies for Non-Oncology

Lead Development