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EMD Millipore is now MilliporeSigma

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

More to Explore...

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.

Biotech Resource Hub: Stay Current

Advance Biotech Grant Program – Accelerating Therapeutic Development in Life Science

The Life Science business of MilliporeSigma is expanding its commitment to the global biotech community with its Advance Biotech Grant Program. Through the newly expanded grant program, every six months, three recipients around the globe will be awarded a total of €200,000 in free services and products to address their process development challenges. In total, six companies will benefit from the Advance Biotech Grant Program each year. Press Release

Find out more about our programs:

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: 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 MilliporeSigma.
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.

© 2017 Merck KGaA, Darmstadt, Germany and/or its affiliates. All Rights Reserved.
EMD Millipore is a part of Merck KGaA, Darmstadt, Germany.