1. Formulation and Process Design:

Customized Formulations: Tailoring formulations to meet specific therapeutic needs and optimize drug delivery.

Robust Process Design: Developing processes that ensure scalability, reproducibility, and compliance with regulatory standards.

 

2. Scale-Up Optimization:

Optimized Scaling Processes: Ensuring smooth transition from laboratory-scale processes to pilot and commercial-scale production.

Efficiency Maximization: Identifying opportunities for optimization during scale-up to enhance efficiency and reduce costs.

 

3. Technology Transfer Planning:

Comprehensive Planning: Developing detailed plans for the transfer of technology between development and manufacturing sites.

Risk Assessment: Conducting a thorough risk assessment to identify and mitigate potential challenges in the transfer process.

 

4. Regulatory Compliance:

Guidance Interpretation: Staying abreast of regulatory guidelines and interpreting them to align with specific project requirements.

Documentation Excellence: Ensuring robust documentation practices to support regulatory submissions and compliance.

 

5. Analytical Method Development:

Advanced Analytical Techniques: Employing cutting-edge analytical methods for the development and validation of assays and tests.

Method Transfer Protocols: Creating protocols for the successful transfer of analytical methods between laboratories.

 

6. Equipment Qualification and Validation:

Equipment Selection: Advising on the selection of appropriate equipment for manufacturing processes.

Validation Protocols: Developing and executing validation protocols to ensure the reliability and consistency of equipment performance.

 

7. Process Validation:

Stage-wise Validation: Conducting comprehensive process validation at critical stages of development and scale-up.

Continuous Monitoring: Implementing ongoing monitoring and control measures to maintain validated processes.

 

8. Documentation and Training:

Comprehensive Documentation: Creating detailed documentation for all aspects of the process, from formulation to technology transfer.

Training Programs: Providing training programs for personnel involved in the technology transfer process.

 

9. Quality Management Systems (QMS):

QMS Implementation: Integrating robust quality management systems to ensure consistent product quality.

Continuous Improvement: Regularly reviewing and updating QMS to incorporate lessons learned and industry best practices.

 

10. Post-Transfer Support:

Ongoing Assistance: Providing support post-technology transfer to address any challenges and ensure continued success.

Continuous Improvement Plans: Developing strategies for continuous improvement based on post-transfer feedback and performance monitoring.

 

Conclusion:

Our services in process development and technology transfer are designed to support pharmaceutical companies in achieving seamless and compliant transitions from formulation development to full-scale manufacturing. By leveraging expertise in various dosage forms and adherence to regulatory standards, we enable companies to optimize processes, ensure quality, and meet market demands effectively.