Ricerca Biosciences, an integrated preclinical contract research organization (CRO) providing services to the biopharmaceutical industry, has announced 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 programme 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.”
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.
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 programme from research to product approval.
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.