Your Path to Global Pharmaceutical Compliance

Ensuring Pharmaceutical Excellence and Global Compliance

Pharmaceutical organizations operate in a highly regulated environment where compliance with standards like WHO, PIC/s, EU GMP, and USFDA is not optional—it’s critical. Certification and accreditation validate a company’s commitment to quality, safety, and regulatory compliance, ensuring market access and customer trust. At Qualifyo, we bring decades of GxP expertise to help organizations achieve these essential certifications seamlessly.

Why This Service is Critical for Pharmaceutical Organizations

Regulatory Approval
Ensures compliance with international regulations to avoid costly delays or penalties.
Read More
Market Access
Proper design and layout contribute to seamless workflows, reduced contamination risks, and productivity.
Read More
Risk Mitigation
Reduces operational risks associated with non-compliance and enhances product safety.
Read More

How Qualifyo Provides This Service

At Qualifyo, our expert consultants work collaboratively with your team to:

01

Gap Analysis
Identify compliance gaps against desired certification standards.

02

Action Plan Development
Design actionable roadmaps to bridge compliance gaps efficiently.

03

Implementation Support
Guide and support the implementation of necessary systems, processes, and documentation.

04

Mock Audits & Inspections
Conduct mock inspections to prepare your facility for actual regulatory evaluations.

05

Application & Liaising
Assist in the submission of certification applications and liaising with regulatory bodies.

What We Deliver

Custom Compliance Plans

Personalized compliance roadmaps meeting your organization's specific needs.

Certified QMS Documentation

Quality management systems fully documented to meet certification standards.

Inspection-Ready Systems

Facilities and systems prepared and ready for inspections.

Achieving Certification

Guaranteed successful outcomes for certification or accreditation.

Why Choose Qualifyo?​

  • Global Expertise

    With over 20 years of experience and collaborations with experts worldwide, we bring unparalleled regulatory knowledge.

  • Tailored Solutions

    Custom strategies aligned with your operational goals.

  • Global Reach

    In-depth knowledge of international regulatory requirements.

  • Proven Track Record

    Trusted by pharmaceutical giants across continents.

Client Benefits

  • Faster Certification

    Streamlined processes reduce time-to-certification.
  • Enhanced Reputation

    Certified facilities command greater trust and marketability.
  • Reduced Compliance Risks

    Reduced Compliance Risks
  • Operational Excellence

    Improved quality systems enhance overall efficiency.

Take the Next Step Towards Certification

Ensure your pharmaceutical operations align with global standards through our Certification & Accreditation services.

Let’s Discuss Your Certification
Goals

Schedule a one-on-one consulting session with our experts.

Ready to Begin Your Certification
Journey?

Provide your details, and we’ll send you a customized roadmap and quote.