DOCUMENTATION

EQS consultants provide comprehensive FDA compliance services to the Bio Tech, pharmaceutical, and medical device industries.

EQS staff performs audits and gaps analysis, pre-assessments, and preparation for certification, and develops training protocols.

Through customized approaches that suit your individual needs and cost-effective project management, EQS develops plans and procedures that meet FDA compliance for electronic record criteria under 21 CFR Part 11 for cGMP, GLP and GCP.

STRATEGIC FDA COMPLIANCE PLANNING

EQS provides Bio Tech FDA compliance and regulatory affairs consulting.

Integrating customized implementation of 510(k), cGMP and GCP and process control with BioTech FDA compliance criteria and goals, EQS delivers audit support for domestic and international standards.

We can assist you in response to 483's, warning letters, consent decrees and import detentions.

CONSULTING SERVICES

EQS dynamic staff of responsive compliance experts deliver consistent and effective results. Taking rapidly changing developments in to consideration, they provide innovative solutions that reach into the future.

• Audits and Gap Analysis
• Preparation for Certification
• Internal Audit Support
• Operational Qualification (OQ)
• Installation Qualification (IQ)
• Validation Plans
• Stem Cell Research Regulatory Compliance

Stem Cell Research Regulatory Compliance

Even privately funded stem cell research is subject to federal law and regulation.  EQS offers the strategic compliance planning to ensure that developmental projects 
and commercial ventures will not be impaired by undue regulatory constraints