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CMC documentation and innovations

Our regulatory CMC team provides expertise in all areas of product development, from small molecules to ​biologics. We provide regulatory advice and compile your application for drug substances, pharmaceutical ​excipients, packaging materials, and drug-device combination products. We offer regulatory advice and compile ​your application using phase-appropriate standards, from early development through manufacturing, to ​accelerate your project and advance your product to the clinic.

Scientific report writing:

We specialize in creating scientific and technical reports using a dossier-​centric approach. This ensures consistency, completeness, and readability ​while keeping the final application in mind.

Drug product:

The following reports are essential in the pharmaceutical industry and play a significant role in ensuring ​product quality, safety, and efficacy. These reports include.

• drug product formulation development reports,
  
• drug product manufacturing process development reports,
  
• investigation reports,
  
• criticality analysis reports, and
  
• technology transfer reports.
  

Drug Substances:

The following documents are integral for ensuring the safety and efficacy of drug substances:

• Mutagenicity assessment reports
  
• Nitrosamine risk assessment reports
  
• Criticality analysis reports
  
• Reports on the origin and fate of impurities during the drug substance process
  
• Regulatory starting material justification reports
  
• Process development reports
  
• Proven Acceptable Ranges (PAR) justification reports
  

These reports provide critical information on the chemical and physical properties of drug substances, as well ​as the potential risks and hazards associated with their production. They serve as a foundation for regulatory ​compliance, risk management, and quality assurance. It is essential that these documents are meticulously ​prepared and reviewed by qualified experts to ensure the safety and efficacy of drug substances.

Analytical development

• Stability reports
  
• Dissolution reports including USP Type IV
  
• Microbiology reports
  
• Assay development, including impurity.
  
• Chromophore and non-chromophore detectors
  
• Particle size development report (orthogonal techniques)
  
• Solid state report
  
• Rheological report
  

Regulatory support services

• Justification of specifications
  
• stability studies and selection and design
  
• Briefing Books for scientific advice
  
• Gap analysis
  
• Filing and registration strategy
  
• Variations and Renewals
  

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