Optimizing Quality with Virtual outsourced solutions

We provide a full Marketing Authorization Holder service to companies looking to expedite Commercial launch of their medicinal products in Europe at optimal cost (we provide the local MAH infrastructure as a service).

Ask VQP AI

Our Services

  • Whether you’re exploring EU Market entry, considering the business case for setting up a local affiliate,  VQP provides hands on SME advice to help inform your business decisions and support your Business Development, Global Supply Chain and Quality teams on the specific  licencing requirements for their specific Distribution activities in EU/EEA.

    For small or virtual pharmaceutical companies, VQP enables:

    • Full GxP compliance without building an internal QA department

    • Senior-level expertise at scalable cost

    • Continuous inspection readiness

    • Reduced regulatory risk

    • Credibility with regulators and partners

    What it looks like:

    • VQP are your quality partner during the pre-approval window (IND/IMPD to MA/NDA/BLA submission).

    • VQP provides a "Quality Readiness Program" — a structured 12–18 month engagement that builds the entire PQS from scratch, prepares for PAI (Pre-Approval Inspection), and transitions seamlessly into commercial QP/RP services post-approval.

    • VQP provides regulatory inspection simulation (mock HPRA/EMA audits) as a core product, not an add-on.

    • WDA Setup, Implementation and RP Service:

      From preparing your WDA submission to providing Responsible Person (RP) oversight, we provide a full RP service offering to manage your product Distribution activities in EU/EEA and maintain distribution compliance across all markets.

    • GDP Training and HPRA Readiness

      We deliver tailored, regulator style training, mock HPRA style audits and inspection preparation programs for your warehouse, operations, and QA staff.

      We offer contract RP/DRP services, RP/Quality coaching, help or advice with HPRA inspection remediation actions and custom GDP checklists to build HPRA inspection confidence.

  • Navigating the EU regulatory landscape? We specialize in guiding companies through the complexities of EU/EEA licensing and MAH responsibilities.

    "You don’t need to build a European office, hire a full QA department, and invest heavily before your first commercial shipment. You need a compliant structure — and the right quality partner."

    VQP provide a full Marketing Authorization Holder service to companies looking to quickly launch their medicinal products in Europe (EU/EEA) at optimal cost (no significant investment in local licencing/personnel/affiliate offices), tailored for virtual or non-EU based pharmaceutical organizations.

    What it looks like:

    • Specialist EU market entry partner for Japanese, Korean, Taiwanese, and Gulf-region biotech companies seeking EU marketing authorizations

    • A dedicated "EU Gateway Package" that bundles: MAH establishment, RP/QP appointment, GDP-compliant logistics setup, and regulatory filing support — culturally aware, time-zone-sensitive service delivery.

    • MAH Service Support: We offer comprehensive support for Marketing Authorization Holders as your MAH partner supporting your medicinal product launch in EU/EEA.

    • We manage initial setup and implementation of your local affiliate, product Quality, Supply Chain and Distribution functions, Regulatory representative and Pharmacovigilance coordination. This service is ideal for startups/non-EU companies entering the market or operating virtually, without in-house capabilities needing scalable, expert led support. Available in initial setup, interim operational management, or fully managed serviced models.

  • Whether you’re launching operations or looking to scale rapidly, VQP provides hands on support across your teams Quality Systems, Compliance and Operations functions.

    "Outsourcing quality management is not about reducing standards — it's about accessing senior-level expertise in a scalable, inspection-ready format without the overhead of building an internal department."

    Includes:

    • Virtual Quality Department

      Our team operates as your fully outsourced Quality function, managing setup, implementation and daily management of your Quality System, Compliance and Operations functions. This service is ideal for startups without in-house capabilities needing scalable, expert led support. Available in setup, interim management, or fully managed serviced models.

    • GxP Training and HPRA Readiness

      We deliver tailored, regulator style training and inspection preparation programs for your Operations and Quality staff.

      Includes mock audits, staff coaching, and industry best practice compliance checklists to build HPRA inspection confidence.

Client Feedback

  • "Virtual Quality Partner has been a reliable and knowledgeable partner in supporting our RP and QA operations. Their structured approach to PQS implementation, WDA variation support, and comprehensive quality oversight including training, inspections, and documentation has significantly strengthened our compliance culture. Their collaboration on QTA templates and post-transition support has ensured continuity and regulatory alignment. VQP's consistent hands on engagement has added real value to our Quality Operations."

    RxSource - Director Quality Assurance

  • "Virtual Quality Partner has been instrumental in supporting our Irish affiliate through the provision of expert Quality consultancy services. Their leadership in regulatory oversight, product diligence, and the implementation of a robust Quality Management System has ensured consistent compliance and high standards across our third-party partners. With their proactive management and commitment to excellence, they have significantly contributed to the integrity and quality of our commercial and development-stage products."

    Global Head of Quality - US Pharma

  • “VQP have exceeded my partner expectations in supporting our requirements to facilitate the release of Drug Product into Europe. Knowledgeable, experienced, and flexible in their service offering to meet your needs at every step of the process and the team make it easy to collaborate on your project. Would recommend to anyone who needs support locally or from a remote local such as ours in Perth, Australia.”

    — Senior Vice President, Quality Operations and Regulatory Affairs, BioCina