CONCORD, Ohio--(BUSINESS WIRE)-- Ricerca Biosciences, an integrated preclinical contract research organization (CRO) providing services to the biopharmaceutical industry, is pleased to announce a strategic partnership with Fulcrum Pharma, an Aptiv Solutions company, a leading provider of drug development consulting and regulatory services essential to progress a development program from research to product approval. The collaboration provides unique, value-added capabilities to biopharmaceutical companies by creating a streamlined and efficient process to move a candidate from development to clinical evaluation.
“The Fulcrum Pharma collaboration is an attractive and exciting proposition for Ricerca and our clients. Fulcrum Pharma brings deep experience in IND authorship and regulatory approval, which fits well with Ricerca’s preclinical services in discovery pharmacology, chemical development and drug safety assessment. The relationship greatly expands our ability to serve our clients who are preparing for regulatory submission anywhere in the world,” commented Ian Lennox, CEO of Ricerca.
Ricerca Biosciences provides the full range of preclinical services from early discovery medicinal chemistry, compound screening, profiling and lead optimization through full drug safety, metabolism and efficacy development support, as well as clinical supply and commercial API production capability. Fulcrum Pharma, is a global leader in the provision of strategic and operational regulatory support to assist clients in the authorship and approval of regulatory submissions.
“The collaboration offers our early stage clients a streamlined service to move efficiently through preclinical development to creation of high quality IND submissions,” said Patrick K. Donnelly, Aptiv Solutions’ Chairman and CEO. “This approach, coupled with our expertise in adaptive clinical trial design, will provide our clients with the ability to accelerate the development of their products and stay ahead of the competition.”
About Ricerca Biosciences
Ricerca Biosciences, offers a comprehensive suite of discovery, preclinical and development services to support drug candidates from discovery through IND and NDA on a global scale. Capabilities include molecular through in vivo screening and profiling, medicinal chemistry, IND-enabling toxicology, API process chemistry and cGMP manufacturing of clinical and commercial API. At Ricerca, our scientific excellence and reliable, cost-effective strategies help accelerate your drug discovery programs via our U.S.-based facilities in Concord, Ohio, and Bothell, Washington, and our ISO 9001-certified facilities in Taipei, Taiwan, and Lyon, France. The Lyon facility also holds AAALAC certification.
About Fulcrum Pharma, an Aptiv Solutions company
Fulcrum Pharma is a professional service company providing clients with expert solutions for the development of therapeutic products. The Company provides a full range of drug development, expert consulting, safety and regulatory expertise essential to progress a development program from research to product approval.
About Aptiv Solutions
Aptiv Solutions is a global biopharmaceutical and medical device development services company focused on recognizing, understanding and enabling clients to capitalize on rapid and fundamental changes facing companies developing products in the pharmaceutical, biotech and medical device market. Aptiv Solutions integrates the resources and expertise of six recently merged companies: Averion International, Trio Clinical Research, Fulcrum Pharma, ClinResearch, Niphix and ADDPLAN.
Aptiv Solutions provides innovative, comprehensive and proven product development capabilities, built on an extensive portfolio of services and a worldwide team of more than 700 professionals.
Kelly Sladek, 308-237-5567
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INDUSTRY KEYWORDS: Health Biotechnology Clinical Trials Pharmaceutical Research Science