Simplify Compliance with Expert Contract RP and QP Services

Our expert Contract RPs and QPs ensure your pharmaceutical operations meet every regulatory standard.

Expertise You Can Count On

Guaranteed Compliance

Trusted by Industry Leaders Worldwide

Partner with us today and let us take the stress out of regulatory management .

Ensure Compliance with Experienced Contract Responsible Persons

At Niche Quality, we provide highly skilled contract Responsible Persons (RPs) and Qualified Persons (QPs) to cover short-term or long-term requirements.

Whether you need to fill gaps during staff leave or enhance your team’s expertise, our RPs bring extensive experience to ensure seamless Good Manufacturing Practices (GMP) / Good Distribution Practice (GDP) compliance.

They are available to be listed on your Wholesale Distribution Authorisations (WDAs) and ensure that medicines are stored and transported in line with regulatory standards.

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Are you an RP or QP?

What is a Contract RP?

A Contract Responsible Person is an outsourced expert specialising in managing and overseeing pharmaceutical regulatory compliance.

They serve as a vital link between your business and regulatory authorities, ensuring that all licensing and distribution protocols are strictly followed.

A Contract RP brings flexibility and expertise to organisations looking to meet GMP/GDP standards without hiring a full-time in-house RP.

Key Benefits of Hiring a Contract RP

Cost-Effective Solution: Avoid the expense of hiring a full-time employee while accessing top-tier expertise.

Regulatory Compliance: Meet GMP, GDP and HPRA (Health Products Regulatory Authority) standards with confidence.

Operational Flexibility: Scale services according to your business needs.

The Role of Qualified Persons (QPs)

A Qualified Person is a highly trained professional who ensures pharmaceutical products are imported, manufactured and released following stringent guidelines.

QPs are indispensable for companies aiming to maintain high-quality supply chain standards.

Why Your Business Needs a QP

Compliance Assurance: QPs verify that all processes meet EU regulatory standards.

Expertise: A QP’s in-depth knowledge helps avoid costly regulatory breaches.

Under European Union (EU) law, the qualified person (QP) is responsible for certifying that each batch of a medicinal product meets all required provisions when released from a manufacturing facility within the EU, or imported into the EU!

STILL NOT SURE?

Frequently Asked Questions

We understand that navigating regulatory requirements and compliance can be complex and challenging. That’s why we’ve compiled this FAQ section to address common questions and provide clarity about our services. If you have additional questions, feel free to reach out to our team for personalised support.

What is a Contract Responsible Person (RP)?

A Contract Responsible Person (RP) is an external specialist hired to oversee and manage regulatory compliance for pharmaceutical distribution. They ensure your business adheres to Good Manufacturing Practices (GMP), Good Distribution Practices (GDP) and other legal requirements, providing expertise without the need for a full-time employee.

What does a Qualified Person (QP) do?

A Qualified Person (QP) is responsible for maintaining the safety, quality, and compliance of pharmaceutical products throughout the supply chain. Their role includes verifying compliance with EU regulations, overseeing storage and distribution, and ensuring that every process meets stringent industry standards.

Why should I hire a Contract RP or QP instead of an in-house team?

Hiring a Contract RP or QP offers flexibility, cost savings, and access to specialised expertise. Instead of committing to a full-time hire, you can scale services according to your business needs while ensuring your compliance requirements are met by experienced professionals.

Are Contract RP services compliant with HPRA, GMP and GDP requirements?

Yes, our Contract RP services are fully compliant with Medicines and Health Products Regulatory Authority (HPRA), Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP) guidelines. We prioritise adherence to all legal and regulatory standards.

What industries would benefit from Contract RP or QP services?

These services are particularly beneficial for businesses in the pharmaceutical, biotechnology, and healthcare sectors. Companies involved in manufacturing, distribution, and storage of medicinal products rely on RP and QP services to maintain compliance and streamline operations.

How do I know if my business needs an RP or QP?

If your business handles pharmaceutical products—whether through manufacturing, storage, or distribution—you are legally required to have a Responsible Person (RP) or Qualified Person (RP) to oversee compliance. Our team can help assess your specific needs and provide tailored solutions.

What is the process for hiring your Contract RP and QP services?

Simply reach out to us with your requirements, and our team will guide you through the onboarding process. We'll assess your needs, provide a tailored plan, and ensure seamless integration into your operations.

Do you provide international compliance support?

Yes, our team of Contract RPs and QPs is experienced in navigating both local and international regulatory frameworks, ensuring your business remains compliant wherever you operate.

How do Contract RPs and QPs handle audits and inspections?

Our Contract RPs and QPs are skilled in managing audits and inspections, ensuring all documentation, processes, and systems are in place to meet regulatory expectations.

Can I customise the scope of services?

Absolutely. We offer fully customisable service plans to meet the specific needs of your business, whether you're a small startup or a large enterprise.

Still have questions? Contact us today for personalised assistance with your needs!