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Regulatory Guidance

Stay the Course

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.

Additional Resources

United States
FDA Guidance for biotechnology: For assistance with Food and Drug Administration, including INDs; and information on clinical trials

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The journey from large molecule to approved biotherapeutic is long, costly, complex, and fraught with risk – yet tempting with reward.

Emerging Biotech: Stay Current

Maximize the Value of your Molecule
Join us at BioLabs

As a long-term partner in the life science industry, we recognize the value innovation brings to the future of healthcare and are committed to advancing life science. This is why we are now sponsoring BioLabs NC as Gold Sponsor.

Come and meet our expert team and learn how we can help you advance your molecule and accelerate your lifesaving drugs to market

Wednesday, January 31, 2018
Durham, North Carolina, USA
The Chesterfield, 701 W Main Street


Refresh Startup Battle Winner Announced at Labiotech in Berlin

Merck recently sponsored a program recognizing emerging biotech companies. The Refresh Startup Battle is a unique occasion for Biotech Startups to show the world their awesome ideas as they pitch in front of the best audience European biotech has to offer. Learn more about the contestants and the winner of the Startup Battle.

Find out more about our programs:
Grants | Events | Innovation | Agreements

Bringing 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.

More details about EB Programs>

WEBINAR: Venture Capital Funding: An Insider’s View

Learn more about the ABCs of venture capital including how it works and the role of a corporate venture capital.

Watch >

WEBINAR: Accelerated ADC Development with Integrated Supply Chain Solutions

Learn more about the advantages to work with one source on your mAb, linker/ payload supplies and conjugation services.

Watch Now >

WEBINAR: RNA Based Therapeutics and Vaccines: Bioprocessing Technology Trends

Review the current dynamics in the RNA therapeutics/vaccines market with a focus on process development and manufacturing strategies.

Watch this Webinar >

WEBINAR: Managing Process Scale-up and Tech Transfer

Learn more on points to consider for successful tech transfers with a focus on cGMP training requirements.

Watch this Webinar >

Webinars On-Demand >

WHITE PAPER: 2017 Life Science Executive Summit

Establishing an open dialog within the biotech community....

Read more and download >

The Changing Biopharma Risk Equation

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.

Read the study >

Contact Us

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.

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Merck Millipore is a part of Merck.