Quality Assurance and Compliance

Regulatory Quality Infrastructure That Inspires Confidence

Building robust quality systems is essential for regulatory success. At Veristat, our Quality Assurance and Compliance team provides strategic quality oversight that strengthens your regulatory position—from supporting FDA and global regulatory expectations to developing compliant Quality Management Systems, to acting as your Swiss or EU Marketing Authorization Holder.

With Swissmedic-licensed pharmaceutical entities and a proven track record of inspection success, we provide the quality infrastructure and regulatory credibility that global agencies respect. Whether you need quality system development, inspection readiness support, or European regulatory representation, our QA experts ensure your programs are grounded in accountability to sponsors, study participants, and regulatory authorities.

Veristat maintains a record of zero critical findings across the last four regulatory inspections.

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Quality Management Systems & Inspection Readiness

Building Audit-Ready Quality Infrastructure

Veristat develops and maintains comprehensive Quality Management Systems that meet global regulatory standards and withstand agency scrutiny.

QMS Development & Maintenance

Quality Management System design, gap analysis, and implementation
Standard Operating Procedure (SOP) development and document control
GxP training program development and tracking
Computer system validation for all GxP-relevant systems
Quarterly Quality Management Reviews with KPI trending

Compliance & Audit Support

Deviation and CAPA management with risk-based assessment
Change control processes and impact assessments
Internal audit programs and readiness assessments
Vendor qualification and approved vendor list management
Client audit preparation, hosting, and follow-up support

Inspection Support

Regulatory inspection preparation (FDA, EMA, Swissmedic, global agencies)
Mock inspections and gap assessments
Post-inspection CAPA development and responses
Independent third-party GMP, GDP, and GVP audits
Proven track record: Zero critical findings in last four regulatory inspections

European Market Authorization Services

Swiss & EU Regulatory Representation

For sponsors without European infrastructure, Veristat acts as Marketing Authorization Applicant and Holder through our Swissmedic-licensed pharmaceutical entities—SFL Pharma (Switzerland) and SFL Pharmaceuticals (Germany).

Swiss Regulatory Services

Acting as Swiss Responsible Person (RP) and Deputy RP
Swissmedic establishment licenses (ATMP and pharmaceuticals)
Marketing Authorization Applications (MAA) in Switzerland
Swiss MAH services without commercialization requirements
Pre-submission and scientific advice meetings
Local batch release and market surveillance
Quality and Pharmacovigilance Agreements

EU & UK Regulatory Services

Acting as EU Qualified Person (QP) for batch release
EU Marketing Authorization submissions and MAH services
Post-Brexit UK regulatory support
Quality oversight for products across European markets
Recall and quality defect management with health authority notification

Let's Talk. Contact Veristat Today!

We know there are always unknown challenges when bringing novel therapeutics to market, so we've assembled an extraordinary team of scientific-minded experts who have mastered the complexities of therapeutic development enabling sponsors to succeed in extending and saving lives.

Quality Culture & Documentation Excellence

The Foundation of Regulatory Success

Quality excellence at Veristat is built on rigorous adherence to Good Documentation Practices and industry-standard ALCOA principles across all GxP activities.

ALCOA Documentation Standards

All GxP documentation follows industry-standard principles to ensure data integrity:

Attributable – Clear identification of document creators and timing
Legible – Readable and unobscured information
Contemporaneous – Real-time recording of activities
Original – Source documentation maintained unaltered
Accurate – Complete, consistent, and enduring records

Electronic Quality Management

Our comprehensive MasterControl system provides:

Controlled document management with version control
Electronic training management and automated tracking
Compliance reporting with escalation protocols
Complete audit trail functionality for all quality activities

GxP Framework

Good Clinical Practice (GCP) – ICH E6, FDA CFR, and EMA CTR compliance
Good Manufacturing Practice (GMP) – Supporting MAH responsibilities
Good Distribution Practice (GDP) – Supply chain quality oversight
Data Privacy & Security – GDPR, HIPAA, and global data protection compliance

Learn More with These Resources

https://www.veristat.com/hubfs/CaseStudy_Successful-EU-MAA-Submission.pdf

https://www.veristat.com/blog/eu-pharma-package-key-takeaways-for-clinical-evidence-jca-strategy

https://www.veristat.com/pharmacovigilance

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Quality Assurance & Compliance