Frequently Asked Questions
How SOKOL Solves Your Compliance and Quality Challenges
At SOKOL GxP Services, we help life sciences companies meet regulatory standards, improve quality operations, and build skilled teams.
Below are answers to the most common questions about who we are, what we do, and how we deliver results.
If you don’t find what you’re looking for, contact us directly.
About SOKOL
SOKOL GxP Services provides Commissioning, Qualification, and Validation (CQV), Compliance, and GMP Training services for life sciences organizations. Our experts help clients design, qualify, and maintain facilities and systems that meet FDA, EMA, and global GMP requirements.
We are headquartered in Pennsylvania and support projects across the United States. Our professionals work both on-site and remotely to provide flexible, responsive support for every client.
We serve pharmaceutical, biotechnology, and cell & gene therapy companies, along with CMOs and CDMOs that need rapid, compliant project execution.
Yes. We specialize in scalable compliance frameworks that help early-stage companies establish solid systems from the start — saving time, cost, and effort as they grow.
Absolutely. We provide field-ready specialists who integrate seamlessly with your internal staff to support CQV, documentation, and quality operations during high-demand or expansion periods.
Regulatory & Quality Solutions
We apply Good Documentation Practices (GDP), standardized templates, and QA oversight to ensure every document meets FDA, EMA, and GMP expectations. This structure minimizes errors, guarantees traceability, and ensures inspection readiness.
Our skills-first staffing model provides trained specialists with both technical and regulatory expertise, reducing onboarding time and maintaining compliance from day one.
We operate with lean overhead and proactive scope management to prevent rework and hidden costs. Our transparent delivery model keeps your project on schedule and within budget.
We use Agile Project Planning, clear milestones, and proactive risk management to maintain quality while meeting critical deadlines.
Our standardized processes, QA reviews, and culture of accountability ensure consistent, reliable results across every engagement—regardless of scope or location.
Services & Expertise
We combine technical precision, regulatory insight, and practical experience. Our lean operations and standardized methodologies deliver consistent, measurable, and audit-ready outcomes.
Yes. Through the SOKOL GxP Academy, we deliver interactive GMP and compliance training covering GDP, Deviation Management, GMP Cleaning, and more. Programs are designed to upskill teams and prepare them for real-world GMP environments.
Absolutely. Our experts conduct internal audits, identify risks, and implement Corrective and Preventive Actions (CAPA) to strengthen your quality systems.
Yes. We offer customized compliance programs that help new organizations establish documentation systems, quality frameworks, and inspection-ready environments efficiently.
Client Collaboration
We maintain open communication and apply Agile Project Management to set clear expectations, define milestones, and prevent delays or cost overruns.
Yes. Our professionals integrate directly with your team on-site or remotely, depending on your operational needs.
All deliverables follow GDP principles and are reviewed under QA oversight. Our version-controlled documentation ensures full traceability and compliance.
Engagement begins with a discovery consultation to understand your goals and challenges. We then develop a tailored proposal with defined milestones and deliverables for transparency from the start.
Training & Development
The GxP Academy is our in-house training platform that develops workforce skills in GMP compliance, cleaning validation, and quality systems. It combines classroom learning, e-learning, and hands-on simulations.
Our programs are open to SOKOL employees and industry partners seeking to enhance their GxP knowledge and operational excellence.
Yes. We create site-specific modules that align with your SOPs and quality requirements—covering deviation management, documentation, and facility-specific GMP practices.
Careers & Culture
At SOKOL, collaboration, integrity, and growth define our culture. We value every team member’s voice and emphasize accountability, innovation, and continuous learning.
We blend the structure of a professional services firm with the flexibility of a learning organization. Through mentorship and development programs, we promote inclusivity, teamwork, and work-life balance.
We hire CQV Engineers, Quality Specialists, Compliance Analysts, Trainers, Project Managers, and professionals in operations, HR, and marketing — all contributing to advancing compliance and quality excellence.
Absolutely. We invest in professional development through continuous learning, mentorship, and structured training within the SOKOL GxP Academy.
Yes. We prioritize flexibility and well-being, fostering a healthy balance between personal life and professional excellence.
Visit our Careers Page to view openings or follow us on LinkedIn for updates.
Working With SOKOL
We start with a consultation to review your project scope, timeline, and compliance objectives. From there, we provide a detailed proposal outlining milestones and deliverables to ensure alignment from the outset.
Each engagement follows GDP principles, QA oversight, and standardized templates. This ensures every document is complete, accurate, and inspection-ready.
Yes. We offer hybrid and remote consulting options using secure collaboration tools and document control systems to maintain efficiency and compliance.
