Our Services

Quality & Regulatory

At Dr. Hotha’s Life Sciences LLC, we provide expert guidance to navigate the complexities of global regulatory environments, ensure the highest quality standards, and drive operational excellence through Six Sigma and matrix management.

Quality & Regulatory
Audit Preparation & Response

Supporting FDA, MHRA, and other regulatory audits. Addressing 483 observations, CAPAs, and quality assurance deviations. Proactive engagement in quality management and data review for compliance.

Providing expert consulting on regulatory submissions for INDs, NDAs, ANDAs, and global regulatory requirements. Assisting with FDA inspections, audits, and filings to ensure adherence to all regulatory stages.

We assist with regulatory filings, FDA inspections, and compliance reviews at every stage, ensuring your product’s development process adheres to industry standards.

We provide rigorous support for internal and external audits, focusing on data integrity, consistency, and preparation for regulatory scrutiny.

Our experts craft and review proposals, aligning them with your strategic objectives to ensure they are competitive and well-positioned for success.

We facilitate seamless technology transfers from development to commercial-scale manufacturing, ensuring all processes are robust, compliant, and scalable.

Evaluating your CDMO partners’ capabilities and compliance to ensure they align with your project requirements and regulatory expectations for successful execution.

We apply Six Sigma methodologies and operational excellence principles to improve efficiency, reduce costs, and optimize productivity across your drug development and manufacturing processes.

Implementing matrix management strategies to streamline decision-making, improve cross-functional collaboration, and ensure accountability across your organization.

Why Choose Us?

Decades of Expertise

With over 20 years of experience in pharmaceutical and biotech sectors, we specialize in both small and large molecule development, bringing unparalleled knowledge to every project.

At Dr. Hotha’s Life Sciences LLC, we believe in true collaboration. We partner with you to fully understand your unique needs and develop solutions tailored to drive your success.

Our plan is to strategically guide your projects through regulatory approvals, successful market launches, and optimize costs, ensuring the highest level of efficiency and compliance.

Leveraging our extensive network of contacts across the US, UK, India, and China, we provide the support and insights needed to help your business thrive in diverse markets. Our solutions ensure smooth and efficient drug development and seamless market entry, drawing on global expertise and partnerships to drive your success.

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.