Quality Audits & Compliance

Quality Assurance Consulting:

Contract Head of Quality

Hayat Pharmaceutical Consulting (HPC) can act as Contract Head of Quality for clients and support full operational QA work with our broad knowledge of pharmaceutical manufacturing processes.

GMP Auditing

With HPC extensive auditing experience and current, detailed knowledge of the global regulatory authority requirements (such as ICH, FDA, EU, Japan). We provide our clients with comprehensive, high-quality audit reports to ensure compliance with all aspects of EU and US GMP guidelines including API, Drug Product, Packaging and Laboratory Facilities including vendors, suppliers of raw materials and packaging materials.

Inspection Readiness

HPC team has expertise to perform and support pre-approval inspections, supplier qualification, routine and for-cause GMP audits, and inspection readiness and programs.

Quality Management Systems

HPC team has reviewed and improved our clients SOPs, forms, Quality Policy manuals, and entire Quality Management Systems. We have also developed complete lean and phase-appropriate Quality Management Systems for pre-clinical and start-up clients.