MMS Blog

  • One Small Secret to a More Successful Briefing Document

    Posted on 9/23/2014 3:27 PM

    Many of us who work in the pharmaceutical industry can recall excitedly explaining aspects of our science to friends and family. Perhaps the discussion took the form of a conversation of food effect around the thanksgiving table, or a detailed breakdown of a mechanism of action to a curious high school biology student. The questions that arise from discussions are often illuminating—allowing us to see science in a different way and helping us explain it more convincingly in the future. While dis

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  • Probiotics – Food for Thought?

    Posted on 9/9/2014 3:31 PM

    In your food, at your doctor’s office, in your body… these microorganisms seem to be supplementing our diets, supplementing our medications, and inhabiting our daily lives. But does anyone really know what they are or who’s monitoring their use? Google advertises brand name probiotics with claims to be gastroenterologist recommended and clinically tested. Further down the page, search results produce definitions of probiotics from sites such as WebMD and Wikipedia declaring the health benefits

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  • Case Study: MMS Support for Small Pharma

    Posted on 9/2/2014 3:35 PM

    Challenge: Sponsor needed Regulatory Project Management for Phase 2/3 Program A small pharmaceutical company had the need for regulatory project management and regulatory document management to support their Phase 2/3 program. The sponsor selected MMS because of the strength of our teams, infrastructure, and regulatory experience. MMS Solution: Provide Regulatory Team to Manage the Phase 2/3 Project MMS provided a regulatory team, including regulatory project manager, regulatory operations sp

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  • The COMPETE Act of 2014 – Extending the R&D Tax Credit

    Posted on 8/26/2014 3:38 PM

    Senator Tom Carper (D-Del) recently introduced the Competitiveness and Opportunity by Modernizing and Permanently Extending the Tax Credit for Experimentation Act of 2014, otherwise known as the COMPETE Act of 2014, in Congress. This bill seeks to amend the Internal Revenue Code of 1986 to increase and make permanent the alternative simplified research credit. Supported by the Association of Clinical Research Organizations (ACRO) and Biotechnology Industry Organization (BIO), the COMPETE Act of

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  • Five Great Reasons to Work at MMS Holdings Inc.

    Posted on 8/19/2014 3:46 PM

    Working in Human Resources, I perform a wide variety of tasks. The one thing I love doing most in my position is interacting and sometimes meeting our colleagues before they join our company. I have the opportunity to tell them why I love working for MMS and why they will too. Anytime I am asked the question, “Why do you like to work for MMS?” I never have to pause to think. I could name many reasons why I love coming to work every day, but here are the top five: 1. The Atmosphere We are a mid

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  • Case Study: MMS Support for Epilepsy Submission

    Posted on 8/12/2014 3:50 PM

    Challenge: Mid-sized Pharma Requests Help Integrating Data for Agency Presentation A mid-sized pharmaceutical company located in the Midwest was planning for a New Drug Application (NDA). Concerns were raised regarding the feasibility of this submission given the large volume of data requiring conversion into an electronic format and integrated for an agency presentation. The epilepsy submission included more than 40 studies worth of data from a wide variety of sources in various formats. Limi

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  • Whitepaper Preview: 505(b)(2) NDA: Navigating the Regulatory Pathway

    Posted on 8/5/2014 3:55 PM

    Review and Approval of new drugs by the Food and Drug Administration (FDA) is the foundation of drug safety in the United States. Despite this, a number of prescription and over the counter drugs are marketed in the US without FDA approval, often unknown to the patients and health care providers who take and prescribe them. Typically, these are drugs that came to the market prior to the monumental 1962 Food and Drugs Act amendment and, for a variety of historical reasons, have not met the mode

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  • Prescription to OTC Switch – Regulatory Pathways

    Posted on 7/29/2014 4:01 PM

    Recently, we reviewed the regulatory considerations, criteria, and strategies organizations should evaluate when transitioning a prescription drug to an Over the Counter (OTC) drug in the United States. In order to make the transition to OTC, organizations also need to have a fundamental understanding of the regulatory pathways and choose the appropriate pathway for their product. There are two ways to register an OTC in the US, OTC Monograph and New Drug Application (NDA). OTC Monograph System

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