Contract QP, RP and RPi

Contract Qualified Person (QP)

At PharmaGXP, we specialize in providing Qualified Person (QP) services on a contract basis, catering to pharmaceutical companies across the UK and EU.
Our QPs are experts in various dosage forms, including Oral Solid, Liquid, Sterile, Repacking, and Radiopharmaceuticals. We ensure that your products meet rigorous regulatory standards and achieve the highest quality and safety levels required in the pharmaceutical industry.

Why Choose PharmaGXP for QP Services?

Expertise Across Dosage Forms: Our QPs possess deep knowledge and experience in managing a wide range of pharmaceutical dosage forms, ensuring expert oversight for your specific product needs.
Compliance with UK and EU Regulations: We are well-versed in the regulatory landscapes of both the UK and the EU, enabling us to navigate complex compliance challenges efficiently.
Flexible Contract Arrangements: Whether you need interim support, project-specific expertise, or long-term assistance, our flexible contracting options provide the perfect solution to meet your business's unique requirements.

Our Services Include:

PharmaGXP is your trusted partner in obtaining a Wholesale Distribution Authorisation. Our team of experts will assist you in navigating the complexities of the regulatory landscape, ensuring that your operations meet all necessary standards.

Release of Pharmaceutical Products

Ensure all products are manufactured, stored, and distributed in compliance with GMP standards.

Risk Management

Implement robust risk management strategies to safeguard your products and processes.

Audit and Compliance Checks:

Conduct thorough audits and continuous compliance monitoring to uphold the integrity of your operations.

Training and Development

Provide ongoing training and development to enhance your team's capabilities and maintain compliance.

Contract Responsible Person (RP)

At PharmaGXP, we offer comprehensive Responsible Person (RP) services on a contract basis to support your Wholesale Distribution Authorisation (WDA) needs in both the UK and the EU.
Our RPs are highly qualified professionals experienced in ensuring compliance with Good Distribution Practice (GDP) regulations, essential for maintaining the integrity and quality of medicinal products throughout the supply chain.

Why Partner with PharmaGXP for RP Services?

Expert Regulatory Knowledge: Our Responsible Persons are well-versed in the specific GDP requirements of the UK and EU, providing your business with expert guidance to navigate regulatory landscapes effectively.
Tailored Contracting Solutions: We offer flexible contracting options to suit your business needs, whether you require short-term assistance for specific projects or long-term support.
Quality and Compliance Assurance: Our RPs oversee all aspects of your distribution process, from storage to transportation, ensuring every step complies with regulatory standards for product safety and quality.

How PharmaGXP Can Help

Compliance Oversight

Manage and maintain systems to ensure continuous compliance with GDP.

Documentation Preparation

We assist in the meticulous preparation of all required documentation, ensuring accuracy and completeness for a smooth approval process.

Audit and Inspections

Conduct regular audits and prepare for regulatory inspections to uphold high standards.

Training and Support

Provide essential training and updates to your team on GDP practices and regulatory changes.

Contract Responsible Person Import (RPi)

At PharmaGXP, we offer specialized Responsible Person for Import (RPi) services on a contract basis, designed specifically to support companies in compliance with UK regulations for the importation of human medicines.
Our services are essential for businesses seeking or maintaining a Wholesale Distribution Authorisation (WDA) license, ensuring that all import activities adhere strictly to Good Distribution Practice (GDP).

Why PharmaGXP for RPi Services? :

Regulatory Mastery: Our Responsible Persons for Import are experts in the UK’s human medicine regulations, providing your business with the highest level of compliance oversight.
Customized Contract Solutions: Whether you need short-term assistance or ongoing support, we tailor our services to meet your business's specific demands.
Quality and Compliance Focus: We ensure that every aspect of your import process is compliant, from documentation to final product release.

Comprehensive Compliance Oversight

We manage all regulatory aspects of importing medicines, including adherence to GDP.

Audit and Inspection Readiness

Our team prepares and supports your business during regulatory audits and inspections, ensuring you meet all compliance criteria.

Training and Ongoing Support

We provide training for your team to stay current with regulatory changes and best practices in medicine importation.

Manufacturer's Special License for Unlicensed Medicine Import

Obtain Your Manufacturer Specials Import License with PharmaGXP
Navigating the complexities of the MHRA's Manufacturer Specials Import License can be challenging. This essential license permits the importation and distribution of unlicensed medicines within the UK, catering specifically to patient needs when licensed alternatives are unavailable.

Why it is Required?

Access to Unlicensed Medicines: This license allows the importation of unlicensed medicines that may be crucial for treating patients when no licensed alternatives are available in the market.
Regulatory Compliance: The Manufacturer’s Special License ensures that the importation and distribution of unlicensed medicines meet the rigorous standards set by the MHRA.
Legal Assurance for Businesses: Obtaining this license provides legal authorization for pharmaceutical companies to handle and distribute unlicensed medicines within the UK

How PharmaGXP Can Assist in Acquiring a it

Compliance Guidance

We ensure your manufacturing and documentation practices meet MHRA standards.

Application Assistance

Our team expertly handles the preparation and submission of your application, ensuring a smooth and compliant process.

Regulatory Expertise

We offer in-depth advice on regulatory requirements, helping you navigate the approval process with ease.

Controlled Drug License from Home Office

Secure Your Home Office Controlled Drug License with PharmaGXP
The Home Office Controlled Drug License is a critical requirement for businesses handling, storing, or distributing controlled substances. This license ensures that companies operate within the strict legal frameworks designed to prevent misuse while ensuring that these substances are available for legitimate medical, scientific, and research purposes.

Why is a Controlled Drug License Required? :

Regulatory Compliance: Adheres to stringent regulations set by the Home Office to manage controlled substances responsibly.
Operational Legality: Enables lawful handling and distribution of controlled drugs, essential for operations in the pharmaceutical and healthcare sectors.
Safety and Security: Maintains high standards of security and control measures to prevent unauthorized access and misuse.

How PharmaGXP Can Assist in Acquiring a Controlled Drug License

Comprehensive Guidance

PharmaGXP provides expert advice on the specific regulatory requirements for handling controlled substances, ensuring your business complies with all legal obligations.

Documentation and Application Support

Our team assists in preparing and submitting all necessary documentation, ensuring completeness and accuracy to facilitate a smooth licensing process.

Ongoing Compliance Support

Beyond obtaining the license, PharmaGXP offers continued support to ensure that your operations remain compliant with evolving regulations.

Why Choose PharmaGXP?

Expert Guidance

Our team has extensive knowledge of regulatory requirements, ensuring that you remain compliant throughout the process.

Seamless Process

We manage the entire application process, minimizing stress and helping you secure your license quickly.

Dedicated Support

We offer ongoing support, from the initial consultation to maintaining the license.

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