Our Services

Analytical Operational Excellence

Our analytical services provide end-to-end solutions, ensuring your products meet the highest industry standards and regulatory requirements as per FDA, EMA and ANVISA Guidelines.

Analytical Operational Excellence
Analytical Characterization

Offering full-scale analytical characterization for small and large molecules, ensuring that every drug substance and product meets top-tier quality and compliance. Provide expert SME Consulting in ADCs, Oligonucleotides and Peptides CMC Characterization support.

We design and manage advanced Analytical R&D (ARD), Quality Control (QC), and High-Potency labs, fully equipped with cutting-edge instrumentation, tailored to your specific needs and operational goals.

Conducting thorough evaluations in drug product formulations and container closure systems to ensure that extractable and leachable compounds comply with safety and regulatory guidelines, safeguarding product integrity.

We specialize in assessing potential genotoxic impurities (PGTI), identifying and mitigating risks to ensure the safety and efficacy of your products.

Providing comprehensive assessments to verify that residual solvents comply with regulatory safety standards, ensuring the highest level of product safety.

With extensive experience, we offer consulting and testing services for controlled substances, ensuring full regulatory adherence and compliance with global standards.

Offering expert guidance on developing and validating robust analytical methods tailored to your drug substances and products. Ensuring methods for HPLC, UPLC, GC, LC-MS, and other analytical techniques meet regulatory standards with precision and accuracy.

We provide comprehensive consultation on the design and execution of stability studies for drug substances and products. This includes both real-time and accelerated studies to ensure product safety and efficacy over time. Our expertise covers monitoring stability under various environmental conditions, ensuring long-term viability, and compliance with regulatory requirements for product shelf life.

Offering consulting services for the qualification of reference standards, ensuring reproducible and accurate results in all analytical processes. Supporting documentation and data generation for successful regulatory submissions.

Expert consultation on impurity profiling, including identification and quantification of degradation products and process-related impurities. Ensuring that products meet regulatory limits for impurities to maintain the highest safety standards.

Providing consulting support for assessing and quantifying elemental impurities in drug substances and products, ensuring compliance with ICH Q3D guidelines.

Offering expert advice on polymorphic forms and solid-state characterization, helping to optimize crystalline structure for bioavailability and regulatory requirements.

Consulting on particle size analysis using advanced techniques such as laser diffraction, ensuring drug substances and products meet formulation and performance requirements.

Guiding the design and execution of forced degradation studies to assess the stability and degradation pathways of drug substances, ensuring stability-indicating methods are developed.

Providing consulting services for the development, validation, and transfer of bioanalytical methods to support preclinical and clinical studies, including PK/PD and immunoassays.

Providing expert consultation on extractables and leachable testing for packaging materials, ensuring safety and compliance with regulatory guidelines.

Offering consulting on the development of dissolution methods to ensure that drug release profiles meet regulatory requirements and product performance expectations.

Providing guidance on the use of NMR, FTIR, UV-Vis, Raman, and other spectroscopy techniques for drug substance characterization and regulatory submissions.

Performing GMP compliance audits and offering consultation on improving laboratory practices, data integrity, and quality control systems to meet regulatory expectations.

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.