FQS Pharma

About FQS

FQS Pharma is a trusted pharmaceutical quality and regulatory services partner supporting companies across the EU and UK pharmaceutical supply chain.

Specialising in GMP, GDP, QP, RP/RPi, MIA, IMP and WDA support, FQS delivers practical, commercially focused compliance solutions to pharmaceutical manufacturers, distributors, market authorisation holders, and healthcare supply chain partners for both commercial and clinical products.

In addition to consultancy and quality oversight services, FQS provides clients with the ability to utilise FQS Pharma’s MIA, IMP and WDA authorisations to support compliant importation, QP certification, RPi release, and distribution activities across the EU and UK markets.

Our experienced team provides hands-on support across quality assurance, regulatory compliance, importation, batch release, temperature mapping, and supply chain oversight. We work closely with clients to deliver solutions that are compliant, efficient, and operationally effective.

At FQS, we pride ourselves on being responsive, collaborative, and solutions-driven. Clients value our technical expertise, proactive approach, and ability to integrate seamlessly as an extension of their own quality and regulatory teams.

Known for our “can do” attitude and commitment to operational excellence, we help organisations navigate complex regulatory environments with confidence while maintaining the highest standards of quality, compliance, and patient safety.

What We Do

We help pharmaceutical companies simplify complex regulatory requirements and maintain compliant, efficient operations across the product lifecycle.

From importation and batch release to GDP/GMP compliance, temperature-controlled supply chains, audit readiness, and quality system support, FQS provides practical expertise that helps businesses reduce compliance risk, accelerate market access, maintain inspection readiness, and support long-term operational continuity.

Services

Utilise FQS Pharma’s MIA (Commercial and IMP) & WDA Services

FQS Pharma supports pharmaceutical companies with compliant EU and UK market access through the utilisation of FQS Pharma’s Manufacturer’s Importation Authorisation (MIA) and Wholesale Distribution Authorisation (WDA).

Our MIA and WDA services enable clients to compliantly import, certify, release, and distribute medicinal products across the EU and UK markets while maintaining full regulatory oversight and supply chain compliance.

Services include:

Importation and QP Batch Certification for Commercial and Clinical Products
RP and RPi Release Activities
EU & UK Market Access Support
End-to-End Regulatory Compliance
Supply Chain & Distribution Oversight
eQMS Integration & Compliance Support
Flexible Operational & Quality Solutions
Ongoing Regulatory & Technical Oversight

By leveraging FQS Pharma’s infrastructure, expertise, and authorisations, clients can streamline operations, reduce regulatory complexity, accelerate market access, and maintain reliable supply chain continuity.

QP, RP & Regulatory Oversight

Qualified Person (QP), Responsible Person (RP), and Responsible Person for Import (RPi) services supporting compliant importation, batch certification, release, and distribution activities across the EU and UK markets.

MIA & WDA Support

Support with Manufacturer’s Importation Authorisations (MIA) and Wholesale Distribution Authorisations (WDA), including regulatory guidance, quality systems, compliance oversight, and inspection readiness.

GMP & GDP Compliance

Practical GMP and GDP compliance support including audits, supplier qualification, gap assessments, quality systems, and ongoing regulatory oversight.

Temperature Mapping & Cold Chain Qualification

End-to-end temperature mapping, warehouse qualification, route qualification, transport validation, and cold chain compliance services supporting GDP, GMP, and WHO requirements.

Quality Management Systems (QMS)

Implementation, remediation, review, and continuous improvement of pharmaceutical quality management systems designed to strengthen operational compliance and business continuity.

Audit & Inspection Readiness

Regulatory inspection preparation, mock audits, supplier qualification, and compliance support to help organisations maintain ongoing inspection readiness.

Online Pharmaceutical Training

FQS Pharma delivers fully online, self-paced pharmaceutical training programmes designed specifically for busy industry professionals working within GMP and GDP regulated environments.

Courses are developed by experienced pharmaceutical quality and regulatory specialists and combine practical industry knowledge with current EU regulatory requirements.

Training programmes include:

Responsible Person (RP) – Good Distribution Practice (GDP)
Good Distribution Practice (GDP)
Good Manufacturing Practice (GMP)
GDP Bona Fides Training
Temperature Mapping & Qualification of GMP/GDP Areas
Guidance for Laboratories: Out of Specification (OOS) Investigations

Flexible online access allows participants to complete training at their own pace while supporting continuous professional development, audit readiness, and compliance awareness.

Testimonials

“FQS is a key part of our Quality Team with a commitment to providing key services including critical operational services such as batch review and QP release in line with market requirements. The team has demonstrated time and time again a robust quality service with a ‘can do’ attitude, practical solutions and wide ranging knowledge.”

— Jasdeep Singh, Head of Quality Assurance, Consilient Health

“As an SME undertaking a substantial premises move in 2025, FQS supported the transition of our WDA and carried out all required Temperature Mapping Studies. FQS were invaluable in taking the project from start to finish. The thoroughness of the mapping, execution, and final reporting left us extremely confident in our submission as part of our licence variation. Could not recommend more highly.”

— Robbie Morley, Group GM, Network Pharmacy