Audit

Auditing services for the pharmaceutical industry: Our pharmaceutical audits are conducted in accordance with the relevant regulatory texts or standards, including GMP, GDP, GLP, GCP, and GVP. We also audit against IPEC guidelines for Pharmaceutical excipients, ISO 22716 (Cosmetics — Good Manufactu...

The OC 11 Platform is the next generation in Global GxP and Data Integrity solutions. It will change how GxP records are generated and will prevent users from complying with global GxP and Data Integrity regulatory requirements.

Convert any Word form into a powerful GxP and Data Integrity syst...

Our team of experts will prepare necessary protocols incorporating all critical parameters


Process Validation:

PharmEng professionals possess experience in validating pharmaceutical and biopharmaceutical manufacturing processes. Our team of experts will prepare necessary protocols i...

Our auditors have real world experience supporting regulatory inspections and preparing companies for pre-approval inspections.

Our team of specialists includes former regulatory agency inspectors and qualified auditors who are proficient in conducting mock inspections, internal 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...

Critical supplier audits performed by industry experts.

A hardware independent SCADA software provides limitless analytics and reporting needs with built in historian. Very Popular for 21CFR11 Compliance in Pharma industry

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...

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...

Conducting clinical trials or launching products for commercialization in Europe can be a challenge. There are many complexities that can impede your efficiency to these markets, such as establishing a legal entity with a Qualified Person (QP) in the region, Brexit, and passing inspections to sec...

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

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 provide solutions and technologies that reduce human intervention and increase efficiency.

Automation is offered in DCS projects independent of the automation vendor. We offer professional services in implementing Automation process control and maintenance in accordance with industry standards ...

Our Subject Matter Experts provide training that fulfill all regulatory requirements

Training is an integral part of GMPs. The operations involved in the manufacture of regulated products are highly technical in nature. Inadequate training of personnel can result in products failing to meet the ...

We help bring concept ideas to life

PharmEng engineers are experienced in building scalable and robust pharmaceutical production facilities and processes while employing state of the art techniques to meet and exceed operational and regulatory requirements.

Our experts have succes...

Our qualified consultants strive to exceed your project goals and objectives

Our flexibility and project experiences range from the qualification of an individual piece of equipment to an entire facility.
Our PharmEng professionals have extensive experience in the development, imple...

A Digital Electronic Log Book - That Can Connect , Collect, Record, Analyze, Create Audit Ready Reports Of The Machine Process Parameters & Identify Their Deviations & Generate Real time Alarms . Eliminating The Manual Loggers & Piled Up Paper Logbook In Industries.

MES Layer Solution For Centralized Data, Record & User Management In Pharmaceutical Industry.

We specialize in Computer System Validation, equipment validation, utility qualification, and IT and OT infrastructure qualification. Our services adhere to the regulatory standards of EMA, FDA, WHO, and other Life Science bodies in Europe and the Americas. With a track record of serving over 180 clients a...

Global Verification & Validation SaaS solution for Life Science companies that complies to EMA/FDA. FIVE Validation developed a SaaS platform that is possible to proceed with validation studies 5x faster, compared to a manual (electronic or paper-based) process.