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...

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...

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 ...

Critical supplier audits performed by industry experts.

Rephine provides a high-quality service in a timely and cost effective manner, from a single advisory activity to full GCP audits, or Quality Management programme and training. Rephine provides tailor-made solutions that meet the unique needs of your organisation.
Rephine’s portfolio of GCP services i...

• FDA/EMA/Health Authority Agency Intelligence • Rapid Response to Inspections • Remediation Support • On-Site Remediation Project Management • Coordination with Regulatory Counsel • Third-Party Support

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...

Quality and compliance solutions delivered by industry-leading specialists

Our experts provide critical GxP-based consulting services throughout the product lifecycle to help our clients successfully bring products to market and maintai...

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

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...

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...

Rephine’s commissioned audit service gives our customers the opportunity to work with us to design exclusive audits tailored to the specifics of their operations. Customers can commission various audits including:

-API Manufacture-Excipient Manufacture
-Investigational Medicinal Product (IMP) M...

Rephine provides personalised, detailed and comprehensive GMP audit reports that are recognised and accepted by QPs and regulatory authorities around the world. The Rephine list of audit reports is updated regularly.

If the audit you require is not on the list, you can review the Rephine Audit P...