Audit

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 ...

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...

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...

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...

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 ...

Our experts ensure clients' safety by protecting them from pharmaceutical hazards

At PharmEng Technology, we understand the importance of evaluating the toxicity and safety of biopharmaceuticals, therapeutic proteins, chemicals, active pharmaceutical ingredients, and components.

P...

We protect the integrity and quality of your temperature sensitive pharmaceutical products to meet all regulatory requirements

PharmEng Technology has developed standards and methods to perform thermal process ratings according to your specifications. Our professionals are equipped with the righ...

We establish and manage quality systems specifically tailored to clients’ operational needs.

Our clients understand the importance of establishing a robust quality system; The effort in maintaining a strong quality system not only ensures that the products and services meet the customer expectat...

We provide solutions to meet both local and global regulatory requirements in the most cost-effective manner.

PharmEng supports Pharmaceuticals, Biologics, Over-The-Counter (OTC), Animal Health, Radiopharmaceuticals, Clinical Trial Products, Medical Devices, Combination Products, Natur...

Our experts incorporate the most modern and efficient Project Management techniques to ensure all project goals and objectives are met

PharmEng Technology has recognized that Project Management is essential throughout the Pharmaceutical, Biotechnology, and Medical Device industries.
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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...

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

In addition to our PV physicians, medics, and medical writing team, we offer a full range of customized PV services that are fully compliant and high in quality.

In order to maximize product potential and ensure patient safety, we help our clients ensure regulatory compliance and manage the ri...

Carrying out a set of measures (analysis and preparation of documentation, audit, support of the state certification procedure) in order to certify production sites for compliance with the EAEU GMP requirements.

Documentation Analysis:
- Analysis of the production site availab...

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...