Accelerate Your Drug Development With Novotech—Your Global Partner In Regulatory & Clinical Success

Novotech’s Chemistry, Manufacturing & Controls (CMC) consulting services provide end-to-end support to ensure pharmaceutical products meet rigorous quality, safety, and efficacy standards from early formulation through commercialization. CMC is a regulatory cornerstone for agencies such as the FDA, EMA, TGA, Health Canada, and MHRA, enabling risk assessment, process validation, stability confirmation, and manufacturing consistency.

Novotech helps sponsors integrate robust CMC strategies early, accelerating timelines, optimizing processes, and reducing costs. Their services span four key areas:

• Regulatory Strategy & Submissions – Aligning CMC plans with global requirements, authoring CMC sections for IND, CTA, IMPD, NDA, BLA, and MAA submissions, and preparing for key regulatory meetings.
• Product, Process & Method Development – Designing and validating processes, analytical methods, and formulations; conducting comparability studies, stability testing, process validation, and impurity profiling; overseeing pilot-scale production and technology transfer.
• Manufacturing & GMP Compliance – Performing GMP readiness assessments, identifying compliance gaps, selecting and auditing CDMOs, and implementing scalable commercial manufacturing strategies.
• Quality & Risk Management – Defining Quality Target Product Profiles (QTPPs), reviewing analytical data, conducting regulatory risk assessments, and establishing quality assurance to prevent delays or failures.

With a proven track record of successful global approvals and multi-regional regulatory navigation, Novotech delivers strategic CMC solutions that de-risk submissions, enhance product quality, and speed market access worldwide.