We've Got all the Bases Covered


Auditing Services

  • Gap analysis audits
  • Internal audits
  • Second and third party audits
  • Quality and compliance audits
  • Due diligence
  • Supplier audits
  • Process audits
  • Product audits
  • System audits
  • Preparation training and coaching for industry/supplier/FDA audits
Quality System Design

We design entire quality systems in compliance to standards and regulations by product type.  You're provided with manuals, SOPs, documentation, and staff training. Creation, implementation and management of Quality Systems are executed in compliance to the following Standards and Regulations:

  • ISO 13485
  • ISO 22716
  • ISO 15378
  • ICH Q7
  • IPEC-PQC
  • EFfCI
  • 21 CFR 820
  • 21 CFR 210/211
  • Health Canada
  • ANVISA
  • and others
Compliance Services

  • Process improvement
  • Root Cause analysis
  • Design controls
  • Validation development for chemical and microbial compliance
  • Risk management
  • Complaint investigations
  • Product failure analysis
  • Microbiology testing, cleaning and sanitation of equipment and facilities
  • Deionized water systems management and sampling
  • Warning Letter/Consent Decree Remediation


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