Quality Assurance and Compliance

Quality and Compliance 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 Applicant or 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.

Unlike pure QA boutiques, Veristat’s QA team operates across FDA, EMA, Health Canada, Swissmedic, and global agencies, offering a multi-jurisdictional reach unmatched by competitors. And because we sit within a full-service CRO, our clients can bundle QA and CMC consulting with clinical operations, biometrics, regulatory submissions, and pharmacovigilance under one roof.

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
Targeted GMP/GDP training modules: GMP basics for biotech, Annex 1 sterile manufacturing, ICH Q9 risk management, and in-house seminar formats
Computer system validation for all GxP-relevant systems
Quarterly Quality Management Reviews with KPI trending
Scalable, fit-for-purpose QMS frameworks and lean SOP sets tailored for emerging biotechs and Clincal studies’ sponsors

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
Quality Technical Agreement (QTA) drafting, review, and negotiation with CDMOs, CROs, and CMOs
Structured CDMO/CMO oversight programs: performance monitoring, periodic quality reviews, and escalation management
Independent third-party GMP, GDP, and GVP audits
Independent third-party quality audits in support of M&A, in-licensing, and partnership due diligence

Inspection Support

Regulatory inspection preparation (FDA, EMA, Swissmedic, global agencies)
Mock inspections and gap assessments
Post-inspection CAPA development and responses
On-site inspection support: expert presence during agency inspections, real-time document retrieval, back-room team coordination, and response coaching
Post-inspection response drafting: FDA 483 responses, GMP non-compliance statements, Swissmedic conditions, EMA inspection responses, and structured CAPA plan development

European Market Authorization Services

Swiss & EU Regulatory andQuality Services

For clients without European infrastructure, Veristat acts as Marketing Authorization Applicant and Holder through our pharmaceutical entities: SFL Pharma (Switzerland) and SFL Pharmaceuticals (Germany/European Union (EU)).

For clients with European infrastructure, our EU Qualified Person (EU QP) services cover the full mandate: EU QP batch certification and EU QP audits, IMP release for clinical trials (Phase I–III), import from third countries, EU QP declaration, and full-time, interim, or deputy QP arrangements.

For Switzerland, we provide services via our own establishment licenses covering medicinal products, ATMPs, and stable blood products. In addition, our Fachtechnisch verantwortliche Persons (FvP) / Responsible Persons (RP) can operate on mandate basis for clients.

Swiss Regulatory Services

Acting as Fachtechnisch verantwortliche Person (FvP) / Responsible Person (RP) and Deputy FvP / RP in all official Swiss languages (DE/FR/IT) in line with Swissmedic TI-SMI.TI.17e, covering cold chain and supply chain quality oversight for Swiss-distributed products
Holding Swissmedic establishment licenses (ATMP and pharmaceuticals) to allow Marketing Authorization Applications (MAA) in Switzerland
Holding Swissmedic establishment licenses (ATMP and pharmaceuticals) to act as Marketing Authorization Holder (MAH) in Switzerland
Addressing quality aspects in pre-submission and scientific advice meetings in Switzerland
Swiss Commercial Market release and market surveillance on mandate basis
Setting up Quality and Pharmacovigilance Agreements
On mandate basis, submitting establishment licence applications, maintenance, and inspection readiness for our clients

EU & UK Regulatory Services

On mandate basis, acting as EU Qualified Person (EU QP)
On mandate basis, acting as EU GDP Responsible Person for wholesale distribution, covering GDP compliance and supply chain oversight
Manage EU Manufacturing and Import Authorization (MIA) or Wholesale Distribution Authorization (WDA) applications for our clients
Host MIA and WDA inspection for our clients
On mandate basis, acting as UK RP for import
Quality oversight for market distribution across EU/ EEA
Recall and quality defect management with health authority notification
Develop GMP/GDP audit programs for our clients

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/clients 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