Maintaining quality and consistency at every stage of the pharmaceutical or consumer product development cycle, including commercial manufacture, is essential for regulatory compliance. Chemistry, Manufacturing, and Controls verify that the product is safe and effective, ensuring the connection between the clinical study batches and the marketed product is maintained.
Our chemistry consultants are experts in this area and can guide you through the various CMC requirements for your product to support a regulatory dossier submission.
- GAP assessment of current processes and controls against the regulatory requirements
- Identification of risk and mitigation strategies
- Establishing the quality target product profile (QTPP)
- Nitrosamine risk assessments
- Design and analytical testing requirements of manufacturing process validation
- Analytical development and validation of methods as per ICH Q2 (R2) Guidance
- Design and execution of pharmaceutical development studies in line with ICH Q8 (R2)
- Assessment of container closure systems, including extractable and leachable studies
- Design, execution, and reporting of stability studies to establish bulk shelf life to support manufacturing and to establish product shelf-life
- Compilation of pharmaceutical development report with product specifications and justification
- Batch release testing
- Bespoke studies to provide an in-depth product understanding, such as
- Preliminary product assessments to determine product feasibility or product regulatory readiness
- Competitor product assessment
- Data bridging strategies
- Studies to support pharmaceutical and product development
- Extractables and leachables
- Packaging and stability/shelf-life assessments
Additionally, we offer chemical consultancy to ensure the validated methods and technologies used in your project's trial and testing phase are transferred to Quality Control (QC) for commercial manufacture.