Quality & Regulatory Advisory

Rushi Pharma provides structured Quality and Regulatory advisory support in collaboration with experienced regulatory professionals to assist pharmaceutical companies in meeting global compliance standards.

Regulatory & CMC Support:

• Review of Chemistry, Manufacturing & Controls (CMC) for NCEs and NMEs
• Regulatory documentation strategy support
• Development Quality Assurance guidance
• QbD (Quality by Design) consultation
• CAPA management frameworks

Facility Qualification & Compliance:

• Design, review, and qualification of manufacturing facilities
• Laboratory and packaging unit assessment
• Gap analysis against cGMP expectations
• Remediation planning for QA/RA compliance
• Technology transfer oversight
• Exhibit batch execution guidance

Audit & Due Diligence Support:

• For-cause audits
• Due diligence audits
• Clinical audits (GCP)
• Compliance risk assessment