Process Validation

From pre-clinical development to commercial supply, Patheon by Thermo Fisher Scientific is an industry leader in the development and manufacture of mammalian cell culture drug substances. Patheon offers biotech and pharmaceutical companies the ability to pursue opportunities around the globe with a fully i...

Quality management systems (QMS) are crucial for the success of any business. They provide an accurate way to track and measure quality across all areas of your company. One key benefit of a quality management system is that it establishes clear goals, roles, and responsibilities. It also tracks the pr...

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...

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...

Pharmaffiliates is providing all the Analytical Services (i.e. Method Development, Method Validation & Transfer, Stability Studies, Contract Analysis, etc)

BioDuro-Sundia’s process development services support drug substance production,  providing an efficient path to manufacture API or intermediates. Our extensive services support production of API for GLP toxicology studies, IND-enabling studies, clinical studies, and commercialization efforts. qq...

Testo offers testo 608 thermohygrometer for measurement of humidity/dewpoint/temperature incl. battery. Testo 608-H2 alarm hygrometer reliably indicates when humidity and temperature limits have been exceeded in garden centres, warehouses, cleanrooms, museums, laboratories etc, to name a few.
...

• Indicator for Pre-vacuum Sterilizers Operating At 121°C & 134°C. • Multiple spots with Varied Timing. • Single indicator Suitable for multiple cycle lengths. • Class 5 & 6 indicator. • Indicator with moving bar.

Pharmaceutical companies must be capable of delivering products to the market with the utmost level of quality and safety. At Zamann Pharma Support, we have been aiding large and mid‐sized pharmaceutical companies in solving quality and compliance challenges while ensuring that practicality and qualit...

The validation of a new GxP software is only one part of a vast deployment process. Preparation in the form of new processes, validation documentation, user management systems, life cycle management and training is always needed to ensure fresh software packages are fully compliant. At Zamann Ph...

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...

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 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 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 ...

Measure, analyze and document all IAQ and comfort level parameters using just the NEW testo 400 IAQ measuring instrument – simply, conveniently and in compliance with the standards. High-quality measuring technology, intuitive measurement assistants, versatile documentation options and a comprehensive ...

SAL017 STERIND:  Chemical Indicator Labels for Autoclave (1 Box x 500 labels)Chemical indicator for autoclave

Our development laboratories are well equipped for conducting a diverse range of experiments. These encompass formulation development, cycle design and process refinement, as well as evaluating finished product. Ease of scale-up is accomplished by completing process development studies within a pilot scale...