Maria Smith appointed as Director, Application and Business Development for Proveris Laboratories

Proveris Scientific Corporation, a leading provider of instrumentation and services to advance the science of aerosol and spray products, today announced the appointment of Maria L. Smith, M.Sc., to the newly established role of Director, Application and Business Development for Proveris Laboratories. This is a new position focused on addressing the rapid growth of the cGMP contract test services and the introduction of new technologies. 

Maria joins Proveris with more than 14 years of CDMO experience in the development and test of orally inhaled and nasal drug products (OINDPs). She has extensive experience in spray characterization, as well as working with customers on problem resolution and compliance. She has authored 10 publications on spray characterization and is well known across the industry for her professionalism, experience, and expertise.

Maria will help drive the growth of Proveris Laboratories contract test services through the expansion of new applications and technologies. In addition, she will serve as a liaison to regulatory agencies, industry groups, and customers to educate on new technology approaches and how they can be used to support in-vitro in-vivo correlation (IVIVC) and bioequivalence (BE).   

Proveris Scientific’s President, Chip Leveille, commented, “Maria’s fourteen years of laboratory experience in spray/particulate science (nasal and oral products) with leading CDMO’s brings a deep understanding of drug development and testing as it pertains to inhalation products. She has extensive knowledge of Proveris systems and particle characterization techniques to develop and characterize aerosol and spray delivered drug devices. We are excited to have Maria on board to further establish and enhance Proveris technologies as critical approaches to drug approval and product release.”

 

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, CFDA, and the pharmaceutical industry to generate submission-ready data. Proveris is certified to ISO 9001:2015 by TÜV Rheinland of North America, Inc., and has more than 20 patents issued on its technology.

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.