QP and Quality Services

Batch Release Services (Qualified Person)

Our Qualified Person (QP) services ensure that each pharmaceutical API batch complies fully with GMP standards and regulatory guidelines before it reaches the market. TBD’s QPs perform rigorous reviews, covering manufacturing records, analytical results, and validation documentation, enabling timely certification and release of batches for clinical and commercial use.

We offer flexible QP batch-release models, whether for batches produced at our facilities or manufactured externally, streamlining your supply chain and ensuring product availability and compliance.

Comprehensive Regulatory Support

Navigating the regulatory landscape can be complex and challenging. TBD Pharmatech provides specialized Chemistry, Manufacturing, and Controls (CMC) regulatory services, ensuring accurate and compliant documentation to facilitate smooth and efficient market approvals.

Our regulatory CMC support includes:

• Preparation and submission of regulatory dossiers (ASMF, DMF, CEP)
• Risk assessment for mutagenicity and N-nitrosamines
• Theoretical purge calculations
• Comprehensive GMP documentation (master batch records, SOPs, validation reports)
• Stability study planning, execution, and reporting per ICH guidelines
• Impurity management, including identification and qualification strategies
• Expert consultation on regulatory submissions, inquiries and agency interactions

By partnering with TBD’s experienced regulatory and quality teams, you gain confidence and clarity, accelerating your journey from development to commercial success.