Service

We leverage the latest technologies to ensure that your pharmaceutical products are developed and manufactured to the highest standards

Our GMP Field Support Services Include:

• Qualification and Validation:

  • Equipment Qualification (IQ/OQ/PQ): We perform Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) to ensure your equipment and systems are installed, operated, and performing according to the required specifications.
  • Process Validation: We help you validate your manufacturing processes to ensure consistent product quality and compliance with regulatory standards.
  • Cleaning Validation: We assist in developing and validating cleaning procedures to prevent cross-contamination and ensure product safety.

• Quality Assurance:

  • QA Processes: Implementation and maintenance of robust quality assurance processes to ensure continuous compliance and product quality.
  • Deviation Management: Effective handling and documentation of deviations to identify root causes and implement corrective actions.

• Regulatory Compliance:

  • Regulatory Support: Expert guidance to navigate the complex regulatory landscapes of the FDA and EU.
  • GMP Auditing: Comprehensive GMP audits to assess compliance, identify gaps, and recommend improvements.
  • Documentation: Preparation and maintenance of meticulous documentation to support regulatory submissions and inspections.

• Training and Development:

  • GMP Training: Customized training programs to educate your team on GMP requirements and best practices.
  • Ongoing Support: Continuous support to keep your staff updated on the latest regulatory changes and compliance strategies.

Why Choose Our GMP Field Support?

• Expertise: Our team consists of seasoned professionals with extensive knowledge of FDA and EU guidelines.
• Tailored Solutions: We provide customized solutions to meet the unique needs of your operations.
• Commitment to Quality: We are dedicated to maintaining the highest standards of quality and compliance in all our services.
• Proactive Approach: We help you stay ahead of regulatory changes and ensure continuous compliance.