Manufacturing Services

• Design and Development Services: Designing and optimizing manufacturing facilities to ensure optimal production and compliance.
• Regulatory Compliance Services: Preparing Local Manufacturer project dossier for Licensing submissions.
• Qualification and Validation Services:
  1. Installation Qualification (IQ): Verifying that equipment and systems are installed correctly and meet specifications.
  2. Operational Qualification (OQ): Demonstrating that equipment and systems operate as intended within specified parameters.
  3. Performance Qualification (PQ): Confirming that equipment and systems consistently produce products that meet quality standards.
• Process Validation: Validating manufacturing processes to ensure consistent product quality.
• Computer System Validation (CSV): Validating computer systems used in manufacturing and quality control.
• Documentation & Process Control:
• Risk Management: Identifying, assessing, and mitigating risks associated with product development and manufacturing.
• Documentation and Training: Developing and implementing comprehensive documentation and training programs.
• Auditing and Inspection Support: Preparing for and conducting internal and external audits and inspections.
• Change Control: Managing changes to products, processes, and systems to ensure compliance.
• Technical Writing: Creating clear and concise technical documentation, such as SOPs, protocols, and reports.
• Training on GMP Fundamentals and Manufacturing Operations.