Quality Assurance and Quality Control - 

 

1. Quality Management Systems (QMS): Development, implementation, and auditing of QMS to ensure consistent quality and compliance across all operations.

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2. Audits: Performing various audits, including internal, investigator site, vendor, and process audits, to identify and rectify issues and prepare for inspections.

 

3. Regulatory Compliance: Ensuring adherence to global regulations such as Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), and others by health authorities like the FDA and EMA.

 

4. Risk Management: Providing risk assessments, developing mitigation plans, and conducting ongoing monitoring to proactively address potential challenges.

 

5. Training: Offering tailored training programs on topics like GCP, SOPs, and QMS to enhance staff expertise.

 

6. SOP and Documentation: Assisting with the creation and updating of standard operating procedures (SOPs) and other essential documentation.

 

7. Inspection Readiness: Preparing companies for routine and unannounced regulatory inspections to minimize findings and delays.

 

8. Validation Support: Providing guidance and support for the validation of systems, equipment, and processes.

 

9. QC Support: Assistance to check the quality of pharma and biotech material, semi finished and final product as per IP, BP, USP and In-house formulations.