Frequently Asked Questions

Answers to Common Questions About Our Consulting Services

At V&C Valence, Inc., we understand that navigating pharmaceutical and regulatory compliance can be complex — and choosing a consulting partner is a critical decision.

Below, we answer the most common questions we receive about our services, process, and capabilities. If your question isn’t covered here, don’t hesitate to reach out. We’re happy to discuss your specific needs directly.

Still Have Questions? Let’s Talk.

We know every organization’s challenges are unique — and we’re ready to provide customized support.

Phone: (317) 695-6933

Email: gil@vc-valence.com

Hours: Mon–Fri, 9AM–5PM ET

  • What industries and companies do you work with?

    We specialize in serving organizations across the life sciences sector, including:


    • Pharmaceutical manufacturers (clinical and commercial)
    • Biotech companies (startups to enterprise)
    • Contract Manufacturing Organizations (CMOs)
    • Contract Research Organizations (CROs)
    • Medical device companies
    • Hybrid or virtual operations in need of QA/RA infrastructure

    Our team supports companies at every stage — from early development through commercialization and post-market oversight.

  • What services does V&C Valence, Inc. provide?

    We offer a full range of pharmaceutical and regulatory consulting services, including:


    • Batch record review & certification
    • Internal and supplier audits
    • FDA/EMA inspection readiness
    • Deviation and CAPA investigation support
    • Quality system remediation
    • SOP development and documentation
    • On-site and remote QA/RA support
    • Regulatory response preparation
    • GMP, GCP, and ICH compliance alignment

    Visit our Services Overview to explore each offering in detail.


  • Are your consultants available on-site or remotely?

    Yes — we offer both. Our consultants can work:


    • On-site, for hands-on support, team integration, and facility-based projects
    • Remotely, for flexible, cost-effective support like documentation, investigations, and training
    • Hybrid, combining both models based on the project scope and your operational needs

    We serve clients across the United States and internationally.



  • Do you help with FDA inspections and 483 responses?

    Absolutely. We support clients before, during, and after inspections. Services include:


    • Mock inspections and readiness audits
    • Inspection strategy and document planning
    • Back-room support during active inspections
    • Writing or reviewing 483 and Warning Letter responses
    • Implementing corrective and preventive action (CAPA) plans
    • Post-inspection remediation and monitoring

    Our goal is to help you present a clear, compliant, and confident position to regulators.


  • Can you help us clear a backlog of deviations or CAPAs?

    Yes. We frequently help clients manage and resolve overdue or complex deviation investigations, CAPAs, and change controls. Our support includes:


    • Prioritization and triage of backlog items
    • Root cause analysis
    • Writing or reviewing investigation reports
    • Developing targeted CAPAs
    • Training staff to improve future handling

    Whether your backlog is due to staffing limitations, inspection findings, or system gaps, we help restore timely, compliant processes.



  • What regulatory frameworks do you follow?

    Our work aligns with global life science regulatory expectations, including:


    • FDA (U.S. Food and Drug Administration)
    • EMA (European Medicines Agency)
    • MHRA (UK Medicines and Healthcare products Regulatory Agency)
    • ICH guidelines (Q7, Q8, Q9, Q10, Q12)
    • GxP standards (GMP, GCP, GLP)
    • 21 CFR Parts 210, 211, 11, and others
    • WHO, PIC/S, and local authority expectations where relevant

    We tailor our services to your operational jurisdiction and product classification.



  • Can you help us build a compliant quality system from scratch?

    Yes. For startups, new sites, or growing companies, we offer quality system development services that include:


    • QMS framework design
    • SOP development and document control
    • Training and qualification programs
    • Change control and deviation processes
    • CAPA systems
    • Audit readiness planning

    We create scalable, inspection-ready systems that evolve with your business.


  • Do you sign NDAs or confidentiality agreements?

    Always. Confidentiality is central to our business. We work with highly sensitive data and situations, and we’re committed to protecting our clients’ proprietary and regulatory information. NDAs and consulting agreements are standard in our onboarding process.


  • How do you price your services?

    Pricing is based on:


    • Scope of work
    • Duration of engagement
    • Consultant expertise required
    • On-site vs. remote service model

    We provide clear proposals with defined deliverables, timelines, and estimated hours or project fees. We can support both short-term and long-term engagements.



  • What regions do you serve?

    We are based in Fort Lauderdale, Florida, and support clients across the U.S., Canada, Europe, and other global markets. Remote engagements allow us to collaborate efficiently with international teams. For on-site projects, travel arrangements can be made based on client location and needs.