Pharma & API

Meet full compliance with our customized and cost-effective solutions, while ensuring patient safety and business continuity within the entire product life cycle.

Support packages

Data Integrity

Data Integrity

Protect records and meet the ALCOA+ requirements.

Digital Governance

Digital Governance

All-in-one solutions to coordinate your digital development.

Compliance

GxP Compliance

Avoid slowdowns and costs by preventively assessing every risk.

Laboratory Excellence

Laboratory Excellence

Level up your laboratory to its highest potential.

Quality Engineering

Engineering & Construction

Design your site in compliance with the latest regulations.

Technical Qualification

Commissioning & Qualification

A modern and integrated approach to qualification.

Regulatory Affairs

Regulatory Affairs

Edit, amend and submit the dossier and registrate worldwide.

Trainings

Trainings

Perform and customize trainings for your personnel.

Audits

Audits

Perform all type of audit, either remotely or onsite.

bu-icon-clinical

Clinical Studies

A dedicated service to assure quality and regulatory compliance.

Looking for more services?

We are here to help you.

Getting in touch directly with us is the best way to let us understand your needs.

Annex 1 guide

With the latest release of the Second Issue of 2020 GMP Annex I, the standard for all sterile manufacturers has been widely extended and revised.
PQE Group has collected all the informations you need to comply in an exhaustive guide.

Don’t wait: request the download now for free and get all the insights on sterility assurance.

Drug Compounding Compliance

According to the Drug Quality and Security Act of 2013, FDCA establishes all pharmacies need to comply with USP and other regulations, while outsourcing facilities are required to mantain full cGMP Compliance.

We care about every phase of the product’s lifecycle

In its 20+ years of life, PQE Group has worked with thousands of clients and always applied the latest technologies and discoveries to help companies achieving their full potential.

As an innovation-based agency, we are constantly developing new services and updating our areas of expertise.