WASHINGTON (PRWEB) January 04, 2018
Clinical Network Services (CNS), an international clinical and regulatory service group and Biopharma Global, an Orphan Drug regulatory consultancy, operating as a US based, not for profit corporation, today announced they have signed a cooperative partnership agreement.
This partnership reflects a mutual commitment by CNS and Biopharma Global to provide a broad and a comprehensive suite of regulatory services to meet the increased demand from international markets seeking uniquely experienced regulatory capabilities.
Together, CNS and Biopharma Global offer high-level solutions to the global biotechnology industry through combining CNS’ intelligent global product development & regulatory affairs consultancy arm, BioDesk, with its Australian and New Zealand based early phase clinical services and Biopharma Global’s niche expertise in Orphan Drug Designations (ODDs) to offer an unparalleled suite of product development capabilities.
The Managing Director of CNS, Russell Neal, commented, “We are delighted to be collaboratively working with Biopharma Global and deepening our Orphan Drug expertise through their highly respected regulatory team. We consider this synergy key in providing more effective support for clients as they implement their program strategies and add greater value to their IP”.
James LaFlamme, CEO of BioPharma Global added, “The agreement with CNS provides another dimension to an already highly regarded regulatory team led by our Chief Science Officer Dr. Sandi Heibel and Key Board member and Senior Advisor Dr. Marlene Haffner, the former head of OOPD at the FDA. The partnership allows Biopharma Global to provide a total solution to our clients from concept through marketing approval on a global basis”
About Clinical Network Services
Clinical Network Services (CNS) is an integrated service group focused on product development headquartered in Australia with offices in New Zealand, the UK and the USA, who create value for small-medium sized biotechnology companies by progressing early stage products through phase 1 & 2 clinical trials or the marketplace sooner. CNS offers a unique service where it integrates BioDesk, an intelligent global product development and regulatory affairs consultancy, with our committed, highly experienced Australian/New Zealand clinical services and biometrics team. CNS’ regional clinical advantage is driven by the extremely pragmatic regulatory environment in Australia and New Zealand that makes it possible for clients to enter the clinic quickly, without prior regulatory approval.
CNS offers a uniquely differentiated, customer-orientated, suite of services to clients which enables CNS to guide products efficiently through critical post-discovery development and into initial human trials. Throughout, CNS takes a global development/ regulatory strategic approach to ensure that value is added at every stage of the product development life cycle.
Further information about CNS and its intelligent development services can be found at http://www.clinical.net.au.
About Bioharma Global
BioPharma Global (BPG) is a US-based, boutique corporation that operates as a non-profit, offering world-class FDA & EMA regulatory affairs, strategy, and human capital services to address the needs of emerging and growing biotech companies globally dedicated to rare disease research. With a team that commands extensive knowledge of the health care and life sciences sector and specialized expertise in the orphan drug space, BPG has distinct advantages: a best-in-class regulatory team with over 100 orphan drug submissions to their credit, a collective first-time submission success rate of over 90-percent, a low-risk, project-based pricing model, and a transparent, client-driven approach.
Through an objective and highly iterative thought process, BPG creates a detailed road-map and integrated path forward towards expedited FDA/EMA approval for every client. With cost-effective and time-efficient solutions, BPG represents the best of scientific thought, management principles, and regulatory expertise while maintaining a reputation for creative solutions.
Further information about BPG and its regulatory services can be found at http://www.biopharmaglobal.org.