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Discovery | Pre-Clinical | Phase I | Phase II | Phase III | Manufacturing |
Regulatory | EB Programs
On the journey to commercialization, be sure to stay the course by understanding the global pharmaceutical regulatory landscape.
We are here to help with the alphabet soup of regulation – FDA, EMA, USP, GMP, ISO, CFR requirements. As biologics clinical trials grow more complex and costly – accounting for some 90 percent of clinical trials spending – companies will need help navigating regulatory requirements.
Our Emprove® portfolio and dossier structure meet the latest regulatory requirements and will speed your way through the regulatory maze. With a portfolio of approximately 400 Emprove® products, you get direct 24/7 online access to product information and dossiers through our new Emprove® Suite and the standardized documentation you need to facilitate your qualification and approval processes.
We offer Provantage Laboratory Services for application, validation, and engineering support. Leverage our microbiological monitoring and testing services to optimize your QC workflow and ensure regulatory compliance.
United States
FDA Guidance for biotechnology: For assistance with Food and Drug Administration, including INDs; and information on clinical trials
Funding
Don’t let a good drug go to waste, or too much of its value to third parties, because of funding issues.
Intellectual Property
Watch emerging biotech CEOs share their intellectual property experiences.
The Drug Candidate Journey
The journey from large molecule to approved biotherapeutic is long, costly, complex, and fraught with risk – yet tempting with reward.
Unlock your molecule's potential
2018 Advance Biotech Grant ProgramBringing your molecule to market. As part of our commitment to meet the needs of the life science community, we’ve developed several programs that recognize stand-out emerging biotech companies. These programs are designed to support biotech start-ups and medium sized companies in solving their current bioprocess development challenges to bring the next generation of molecules to market.
Learn more about the advantages to work with one source on your mAb, linker/ payload supplies and conjugation services.
Review the current dynamics in the RNA therapeutics/vaccines market with a focus on process development and manufacturing strategies.
Learn more on points to consider for successful tech transfers with a focus on cGMP training requirements.
Establishing an open dialog within the biotech community....
A report from the The Economist Intelligence Unit sponsored by Merck.
This paper, which incorporates the results of a survey of 254 pharmaceutical executives from around the world and a range of interviews with industry experts, explores in detail global pharmaceutical companies' growth strategies and their plans for managing the associated risks.
Research. Development. Production.
We are a leading supplier to the global Life Science industry: solutions and services for research, development and production of biotechnology and pharmaceutical drug therapies.
