QMS & Regulatory services

We provide technical and regulatory expertise to the Life Sciences Industry.

Our regulatory affairs professionals have in-depth knowledge of ICHQ7, ICHQ9, ICHQ10, and Q1E in addition to extensive cGMP implementation expertise in working with regulatory agencies (RA). We are committed to diligent preparation of all documents for RA and Active Pharmaceutical ingredients manufacturing companies. We make sure that regulatory & customer approval procedures managed by our team run smoothly. Major role in providing scientific guidance to resolve issues related to inspectional findings, reviewed critical SOPs, deviations, investigations, CAPA, Validations & qualifications in a new project, PQR, OOS, OOT, Stability, Batch manufacturing & analytical records and risk assessment, etc.

• GMP & Quality Management System Implementation.
• Qualification & Validation.
• Audits & Compliance
• Regulatory Support
• ISO System Implementation (ISO 9001,14001,45001)
• GMP & ISO Awareness Training.
• Dossier Preparation
• Gap Analysis
• GMP & Quality Management System Implementation.
• Qualification & Validation.
• Audits & Compliance
• Regulatory Support
• ISO System Implementation for ISO 9001,14001,45001
• GMP & ISO Awareness Training.
• Dossier Preparation
• Gap Analysis