Proveris Scientific announces its laboratory compliance with cGMP

Proveris Scientific announces its laboratory compliance with cGMP (Current Good Manufacturing Practices)

Proveris Scientific Corporation, a leading provider of services and technology to advance the science of spray and aerosol products, today announced it is expanding its contract test services laboratory to allow for compliance with cGMP (current Good Manufacturing Practices). This achievement demonstrates Proveris Scientific’s continued pursuit of excellence and mission to help its customers bring optimally-performing orally inhaled and nasal drug products (OINDP) to patients around the world.

Proveris Scientific’s cGMP compliant laboratory operation will now offer submission grade contract test services, as well as development projects, release testing, and stability studies. Compliance with these practices offers customers assurance that test services performed on their drug products meet the highest of quality standards for regulatory submission. The company will also continue to maintain certification to ISO 9001:2015 for both products and services.

The quality system meets both the FDA and EMA cGMP regulations and guidance documents, ensuring systems are in place covering critical areas. These areas include instrument and system validation, personnel training and monitoring, document controls, and control of processes and facilities. It also includes all guidelines relating to process validation, comprehensive corrective and preventive action (CAPAs), vendor qualification, and best laboratory practices, as well as design and management reviews.

Proveris Scientific is the industry leader in providing spray characterization products and technologies for the OINDP market and are experts in spray and aerosol product evaluation. The company has been manufacturing instruments for over twenty-five years and performing OINDP test services for over fifteen years.

“We are excited to elevate our laboratory from its humble beginnings over 15 years ago as the genesis for countless development projects with our customers around the world to the level required for cGMP compliance. This achievement confirms our commitment and continued investment in the OINDP arena and to accelerating the development efforts we are involved in with our customers around the world,” commented Founder and CEO, Dino J. Farina.

“As a testament to our high standards of excellence, we are proud to add cGMP compliance in our laboratory services offering as another milestone in our history,”

commented President, Chip Leveille. “I am very proud of our team here, who make dedication to quality products, services, and the success of our customers a daily focus. It is a great feat for all of us to see our quality culture culminate into this achievement.”

About Proveris Scientific:

Proveris Scientific Corporation advances the science of respiratory drug delivery products by driving new technology development for high performance spray characterization, capture, and analysis, while leveraging its expertise, experience, and core technologies. With customer success as its central motivating force, Proveris Scientific adds value to a global customer base with “complete solutions” which include product innovation, technical services, systems, consumables, and educational training. Since its founding in 1995, the company has accelerated the development of top spray and aerosol drug products and has deployed its systems at more than 100 pharmaceutical development and manufacturing sites around the globe. Proveris’s systems are the industry standard and are used by the FDA, China NMPA (National Medical Products Administration), and the pharmaceutical industry to generate submission-ready data. The company operates under an ISO 9001:2015 certified quality management system and its laboratory operations are cGMP compliant.

 

Proveris Scientific Expands its Technical Service Team

Proveris Scientific expands its technical service team with the addition of engineer Juan Osvaldo Moliére Velez

 Proveris Scientific Corporation, a leading provider of services and technology to advance the science of spray and aerosol products, today announced that it has expanded its technical service team with the addition of engineer Juan Osvaldo Moliére Velez.

Juan will be based at Proveris Headquarters in Hudson, Massachusetts, providing in-house support to Proveris field engineers and directly to customers. He will also be travelling to customer sites to assist with servicing instruments and to train customers on test procedures developed in-house. 

He has 10-plus years of experience, most recently at Illumina where he spent three years installing new gene sequencers, performing preventative maintenance, and on-demand service. Prior to that he served as a field service engineer at Qiagen where he supported customers of the Modaplex system providing direct support and service for in-house systems.

Juan is a mechanical engineer with an educational background based on design and manufacturing prototypes. He has worked for the aerospace industry which provided him with intimate knowledge of jet engine turbines and experience in regulated industries. He has leveraged this knowledge in multiple roles in the medical industry. Juan will report to Proveris Scientific’s VP of Technical Services, Alberto Correia. 

About Proveris Scientific

Proveris Scientific Corporation advances the science of respiratory drug delivery products by driving new technology development for high performance spray characterization, capture, and analysis, while leveraging its expertise, experience, and core technologies. With customer success as its central motivating force, Proveris Scientific adds value to a global customer base with “complete solutions” which include product innovation, technical services, systems, consumables, and educational training. Since its founding in 1995, the company has accelerated the development of top spray and aerosol drug products and has deployed its systems at more than 100 pharmaceutical development and manufacturing sites around the globe. Proveris’s systems are the industry standard and are used by the FDA, China NMPA (National Medical Products Administration), and the pharmaceutical industry to generate submission-ready data. Proveris is certified to ISO 9001:2015 by TUV Rheinland of North America, Inc., and has more than 20 patents issued on its technology.