Our Services

End-to-End CDMO – CMC Management

At Dr. Hotha’s Life Sciences LLC, we provide specialized consulting services designed to streamline every phase of drug development. Our expertise ensures a seamless path from discovery to market launch, from identifying optimal CDMO partners to supporting advanced therapeutic modalities like ADCs, Oligonucleotides, and Peptides.

End to End CDMO - CMC Management
CMC Management

We offer comprehensive Chemistry, Manufacturing, and Controls (CMC) Management to guide your drug development projects through every critical phase. Our services ensure that all aspects of CMC—including drug substance, high-potency drug development, formulation development, analytical methods, process scale-up, and technology transfer—are executed efficiently and meet regulatory requirements. Whether you’re developing a new product or advancing an R&D project, we streamline the CMC process to accelerate your path to market.

We help clients identify and optimize the best Contract Development and Manufacturing Organization (CDMO) partners to ensure alignment between development goals, manufacturing processes, and regulatory standards. Our expertise ensures you choose the right partner for every project phase, minimizing risks and accelerating progress.

Our team provides comprehensive support in drafting, reviewing, and refining proposals. We ensure that your proposals are strategically aligned with your development objectives, enhancing competitiveness in the market. From early drug development stages to commercialization, we support you in presenting the most robust case for success.

We assist in identifying, evaluating, and securing new business opportunities and strategic partnerships. Our insights enable you to expand your market reach, engage with the right partners, and align every opportunity with your long-term vision for growth and success.

From early-stage development to full commercialization, we manage complex pharmaceutical projects with precision. We ensure that timelines are adhered to, budgets remain intact, and that your projects progress seamlessly through every stage of development, allowing you to focus on innovation and market delivery.

With deep expertise in ADCs, we offer specialized support for these advanced therapies, analytical characterization, phase-appropriate safety evaluations, and manufacturing processes. Our approach accelerates the development process, helping bring these critical therapies to market faster while ensuring regulatory compliance and high-quality outcomes.

We provide end-to-end consulting for Oligonucleotides and Peptides, offering guidance through CMC and analytical characterization from preclinical stages to commercialization. Our team ensures that your therapeutic modalities are developed and manufactured with the highest quality and compliance standards.

Data integrity is at the heart of what we do. We maintain the highest quality control standards, ensuring that every aspect of your data—from discovery to delivery—is accurate, thorough, and fully compliant with regulatory requirements. Our data review services guarantee precision at every stage of the development process.

We assist and coordinate controlled substances testing. Our team ensures full compliance with regulatory guidelines to navigate the complexities of controlled substance management throughout the development and commercialization processes.

Our consultation is always in sync with your strategy

We provide comprehensive end-to-end CDMO and CMC management solutions that are tailored to meet your fast-to-market goals. From early development stages to regulatory submissions like INDs, NDAs, and ANDAs, we ensure that every aspect of the Chemistry, Manufacturing, and Controls process is optimized for success. Our expertise in building scalable processes, high-potency labs, and enhancing R&D capabilities supports global operations, driving innovation and ensuring seamless project execution.

Contact us to simplify complexity and accelerate your path to market success.

Our Services

Other services we offer

End to End CDMO - CMC Management
End-to-End CDMO – CMC Management

End-to-end support from concept to commercialization.

Analytical Operational Excellence
Analytical Operational Excellence

Full-scale analytical characterization and lab operations.

Quality & Regulatory
Quality & Regulatory

Navigate FDA and global regulations with expert guidance.

Commercial & Operational Excellence
Commercial & Operational Excellence

Offering precision diagnostics and expertise to enhance efficiency.

Supply Chain Excellence
Supply Chain Excellence

Streamlining your supply chain for reliable, cost-effective solutions in pharma and biotech.

Why Choose Us?

At Dr. Hotha’s Life Sciences LLC, we are dedicated to helping you navigate the complexities of drug development. Download the flyer and feel free to reach out using our contact information.