QP and RP Services
Securing
your pharmaceutical
compliance with
pragmatic QP leadership
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QP / RP Services
At QP Pro Services, our Qualified Persons (QP) and Responsible Persons (RP) are certified industrial pharmacists who provide comprehensive oversight of regulatory compliance. Our team ensures the highest standards in product release, GMP, batch certification, and ongoing operational performance, leveraging real-world expertise in the pharmaceutical industry.
The unique selling points and
advantage of our feature.
Batch Certification & Release
(EU Annex 16)
- Full compliance with EU Annex 16 for batch release and certification, ensuring all medicinal products meet regulatory safety standards before they are released into the market.
- Our QP experts provide batch certification for commercial and investigational medicinal products, handling all the necessary compliance checks to ensure product safety and regulatory adherence.
AFMPS / EMA Representative
& Regulatory Liaison
- Acting as your direct liaison with regulatory authorities, including the AFMPS (Federal Agency for Medicines and Health Products) and EMA (European Medicines Agency).
- We manage all interactions with regulatory bodies to ensure timely updates and seamless communication on regulatory issues, submissions, and compliance.
GMP Oversight
& Regulatory Compliance
- Providing full GMP oversight across manufacturing, quality control (QC), MS&T (Manufacturing Science and Technology), and the supply chain.
- Our QPs ensure that your operations maintain compliance with EU GMP, FDA, and PIC/S standards, providing ongoing support for inspection readiness and GMP performance.
GDP Guidance & Compliance
for Wholesale Distribution
- Expert guidance on Good Distribution Practices (GDP) for the safe and compliant distribution of pharmaceutical products.
- Ensuring that your storage, transport, and distribution practices meet the required standards for temperature-sensitive and controlled substances.
Temperature-Controlled Storage
& Distribution Compliance
- Oversight of temperature-controlled storage for products stored at 2–8°C, −20°C, −70°C, and ultra-cold conditions.
- Full responsibility for maintaining product quality through the distribution process, with transport oversight and risk assessments of transport lanes.
Full Product Lifecycle Responsibility
- Providing end-to-end product responsibility, from the point of entry into the EU market through batch release and up to product distribution.
- Ensuring full compliance with all GMP and GDP standards for the complete lifecycle of your product.
Why Choose QP Pro Services
for QP / RP?
From batch certification to contamination control, our QPs provide end-to-end support across all stages of the product lifecycle.
We understand the intricacies of pharmaceutical operations and regulatory frameworks, ensuring your business remains compliant and operationally efficient.
Our QPs work directly with your teams, providing seamless integration and hands-on support, allowing for quick problem-solving and effective operational strategies.
Where external QP and RP support creates the most operational value.
External Qualified Person and Responsible Person support helps maintain senior oversight without slowing down release timelines, distribution continuity, or market access decisions.
Support can cover batch certification, release governance, GDP accountability, importation interfaces, and continuity for critical QP / RP roles.
Commercial batch certification and release oversight
Ideal when your business needs an experienced QP to review release packages, assess deviations and change controls, and support timely batch disposition without compromising GMP expectations.
Importation governance and third-country interfaces
Useful for products manufactured outside the European Union, where QP oversight, importer responsibilities, technical agreements, and site interfaces need stronger structure and accountability.
RP continuity for GDP and wholesale distribution
Relevant when a wholesale distributor or MAH needs a Responsible Person to maintain GDP oversight, escalation routines, and business continuity during transitions, audits, or organizational change.
Related expertise
EU importation support | Operations consulting | Inspection readiness | Plan the next compliance step
Let’s define your next
compliance step
Share your context below and we will schedule a structured consultation to assess your regulatory and operational priorities.
