RESEARCH & DEVELOPMENT

3. Research & Development (R&D)

• 3.1 Formulation Development

• • 3.1.1 Pre formulation Studies: Investigating the physical and chemical properties of drug substances.

  • 3.1.2 Formulation Design: Developing the composition of a drug product.

  • 3.1.3 Stability Testing: Assessing how the drug formulation behaves under various conditions over time.

• 3.2 Process Development

• • 3.2.1 Scale-Up: Transitioning from lab-scale to full-scale manufacturing.

  • 3.2.2 Optimization: Refining manufacturing processes to improve efficiency and product quality.

• 3.3 Analytical Development

• • 3.3.1 Method Development: Creating and validating methods for testing drug substances and products.

  • 3.3.2 Analytical Testing: Conducting tests to ensure the quality, potency, and purity of drug products.

• 3.4 Regulatory Submissions

• • 3.4.1 Dossier Preparation: Compiling the necessary documents and data for regulatory approval.

  • 3.4.2 Interactions with Regulatory Agencies: Communicating with agencies like the FDA or EMA during the approval process.