Our Approach

Regarding Audits, all of our auditors are IRCA trained to the highest standards.

Training is also a service we offer; we provide tailor-made training modules to suit your needs and fill the gaps.

Audits
in BIOTECH

• Active Pharmaceutical Ingredient (API)
• Contract Manufacturing Organisation (CMO) audit
Pre-Inspection Preparation (MHRA – FDA – EMA – ANVISA – ISO)
ISO 9001
• Mock PAI (FDA)
• Gap Analysis
Remediation Activity Auditing
• Computer System Validation
• GCP audits, investigator sites, CROs
• GPVP audits

Audits
in MEDTECH

QMS IS0 13485
EU MDR – Regulation (EU) 2017/745
EU IVDR– Regulation (EU) 2017/746
510(k)
• 21 CFR 820
• ISO 14971
• ISO 62304

TRAINING in BIOTECH
& MEDTECH

Good Manufacturing Practice (GMP)
• Quality Management System
• Good Distribution Practice (GDP)
• Good Clinical Practice (GCP)
• Responsible Persons Training
• Regulatory Compliance
Technology Transfer
Risk Management
• Six-Sigma
• Computer System Validation
Validation training (Equipment, Process, Cleaning)

Do you already have a project in mind?