Audit

Our pharmaceutical scientists and regulatory experts work with you at every stage of development, providing consistently high quality and flexible services that enable you to achieve a marketplace advantage. Over the last 35+ years, our network of Good Laboratory Practice (GLP), Good Clinical Practice (GCP...

Zenovel provides end-to-end GCP services to support sponsors, CROs, and clinical research organizations across the clinical development lifecycle.

Risk-Based Monitoring (RBM) • BA/BE, PK/PD, and Phase I to IV Clinical Studies • Bioanalytical and PK-Stat Monitoring • Medico Monitoring Clinical ...

We take responsibility for releasing your drug batches in accordance with the requirements of the EU GMP guidelines and the German Medicinal Products Act (AMG).

Our services at a glance: • Batch release in accordance with EU GMP Annex 16 by our QPs • Batch certification for human and veterinary...

Calibrations are performed on any flow rate up to 300 l/min with an uncertainty of 1.8%, through Altiorlab, QSGroup's ISO 17025:2018 ILAC MRA certified laboratory. Calibration can be performed at our laboratory, at the customer’s site or with our mobile laboratories (UOM ISO 17025:2018 certified).

PharmSol carries out a complete chain of audits which assures product safety and quality to clients across the globe for Finished Products, APIs, Intermediates and Key Starting Materials (KSMs). PharmSol has an in-house team of Auditors who are accredited with various certifications including APIC/CEFIC/AS...

We offer various GCP services which can help the clients across globe, ranging from audits to monitoring services. We provide comprehensive GCP Quality Compliance services to the pharmaceutical industry. Our GCP consulting services are characterized by:

1) Knowledge: Various regulatory requi...

Due to recent regulatory developments concerning raw materials, suppliers, manufacturing and distribution, auditing has become a task of critical importance for Life Science businesses.PQE Group supports Pharma and MD companies in performing many types of certified audits, from routine monitoring to due di...

CARICOM is a set of markets with no single registration route. Manufacturers who could serve the region often do not, because the pathway is unclear and no one market justifies the effort on its own.

Barbados is building national regulatory capability, and regional review is available th...

CSV implementation, Data Integrity, 21 CFR Part 11 & Eu Annex 11 Compliance Assessment, Implementation of Lab Applications like Electronic Lab Notebook, LIMS, SDMS, CDS, etc.,

GxP - Third party audits, Validation, Qualification and Engineering services, Remediation projects, Quality, Training &a...

To meet your unique pharma and biopharma outsourcing needs, Intertek delivers quality and safety through pharmaceutical contract laboratory services, regulatory support, and supply chain assurance. We bring quality and safety to life!

With our pharmaceutical experts working with you at ...

Pharmaceutical Auditing Services: Our audits are conducted in line with relevant regulatory standards, including GMP, GDP, GLP, GCP, and GVP. We also audit against IPEC guidelines for excipients, ISO 22716 (Cosmetics GMP), EFfCI GMP for cosmetic ingredients, ISO 15378 for packaging materials, ISO 13485 for...

Intertek provides GMP audit services to support pharmaceutical, biopharmaceutical and healthcare companies in assessing, qualifying and monitoring suppliers, manufacturers and service providers across global supply chains. 

Our audits evaluate compliance with applicable Good Manufacturing P...

As an interdisciplinary team with many years of experience in drug safety, we advise you on all aspects of pharmacovigilance and support you in conducting GVP audits – fully aligned with current GVP guidelines. This includes, among other things, the planning, conduct, and follow-up of your GVP audits.
...

Through Altiorlab, QSGroup's ISO 17025:2018 ILAC MRA certified laboratory, QSGroup can calibrate: 
• Analogue or digital hygrometers
• Hydrographs and thermohygrographs
• Electrical or mechanical thermo hygrometers 
• Thermo-hyd...

Through Altiorlab, QSGroup's ISO 17025:2018 ILAC MRA certified laboratory, calibrations can be performed on any flow rate up to 300 l/min with an uncertainty of 1.8%. This service is available at our laboratory, at the customer’s site or with our mobile laboratories (UOM ISO 17025:2018 certified).

Calibration are performed according to all the points required by ISO 21501 4:2018, the reference standard cited in ISO 14644 – 1:2015 (Annex A) for the calibration of optical particle counters of any brand. Calibration are performed through Altiorlab, QSGroup's ISO 17025:2018 accredited laborato...

This type of calibration activities are performed through Altiorlab, QSGroup's ISO 17025:2018 ILAC MRA certified laboratory. QSGroup is the first and only Company in the world to offer ISO 17025:2018 ILAC MRA certification on TOC.

The determination of the T.O.C. (Total Organic Carbon) in ...

PharmSol does not limit itself only to offering Audits, but we expand our solution offerings to ensure complete Compliance at the client’s site. Towards obtaining GMP Certification from Europe, United States or WHO, PharmSol has a very effective, systematic and rational approach in providing solutions effi...

Preparing for a USFDA Inspection and managing the post inspection situation requires a high level of expertise and PharmSol offers a comprehensive solution in that direction.-Compliance Management
-Product Development
-Regulatory Support
-BD Support

We offer various GMP services which can help the clients across globe, ranging from audits to various consulting services.

We provide following comprehensive GMP Quality Compliance services to the pharmaceutical industry.

• Audits 

• API Audit Reports 

• QMS/Complia...