Audit
Audit Companies (24)
Audit News
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News Mitigating supply risk: Having feet on the ground during COVID-19
Having personnel on the ground may be central to mitigating supply chain risks, even as the world embraces the remote approach.
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Sponsored Content Audits in the time of COVID-19 – Implications for a CMO
Travel restrictions imposed by the pandemic have limited the ability of pharmaceutical companies and health authority personnel to travel and conduct in-person inspections of contract manufacturing organizations (CMOs). Due to t... -
News GVK BIO Announces USFDA Approval for its cGMP Analytical Services Laboratory
GVK BIO, a leading global Contract Research and Development Organisation, announced today that United States Food and Drug Administration (FDA) has approved its cGMP Analytical Service Laboratory located at IDA, Mallapur Campus, Hyderabad.
Audit Products (36)
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Product GVP-Audits services
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.
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Product ISO 17025:2018 Flow Meters Calibration
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).
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Product Auditing, Consultancy & Training
EU GMP / EU GDP Auditing, Consultancy and Training
We support pharmaceutical manufacturers and supply chain partners in achieving and maintaining compliance with EU regulatory requirements. Our services strengthen quality systems, improve inspection readiness and support sustainable GMP / GDP complian...
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Product Pharmaceutical Auditing Services
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...
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Product GMP / QP Audits
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...
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Product GCP Services(Good Clinical Practices)
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...
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Product Audits
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...
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Product GMP audits
Ideolon’s GMP audit services provide end-to-end solutions for supplier qualification, including audit planning, execution, CAPA follow-up, and closure. With experienced auditors and global regulatory expertise, we help ensure compliance with standards like USFDA, EMA, UKMHRA, ICH, and more.
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Product Computerized System Validation (CSV) and Compliance Service
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...
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Product Batch release
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...
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Product ISO 17025:2018 Temperature Probes Calibration
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...
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Product Portable and Remote Air Microbiology Samplers Calibration - ISO 17025:2018 ILAC MRA
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).
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Product ISO 17025:2018 T.O.C. Calibration
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 ...
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Product ISO 17025:2018 Portable and Remote Particle Counters Calibration
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...
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Product Compliance Management
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...
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Product USFDA Compliance & Regulatory
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
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Product GMP Services(Good Manufacturing Practices)
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...
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Product Asia's First Live audit report Library
Ideolon's Audit Report Library offers quick access to a wide range of ready-to-use GMP audit reports across API, FDF, and excipient suppliers in Asia. It helps clients save time, reduce audit costs, and accelerate supplier qualification with reliable, high-quality reports.
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Product Advanced Remote Technologies
Our industry is rapidly evolving to cope with the challenges posed by new markets and the recent COVID-19 global pandemic that has systematically changed our working habits.Choosing PQE Group as your partner, you can perform audits, assessments, validation tests and training safely and remotely.
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Product pharma quality services for drug importation, QC testing, QP release, and audit support into EU
At A-Squared Pharma, we partner with pharma and biotech companies to simplify EU market entry for investigational and commercial medicines. Our HPRA-authorised services include drug importation, QC testing, QP release, and audit support. We combine speed, compliance, and scientific rigour to...
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