MMS Blog

  • 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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  • Using Heat Maps in Pharmaceutical Data Analysis

    Posted on 7/22/2014 4:11 PM

    The Heat Map, broadly used in various fields of study, is an efficient way to convey an abstract concept or a large amount of information via graphical figures through which data patterns (or the lack of) can quickly emerge and be analyzed. It consists of a colored base image body and two separated dendrograms (optional) at the top and left side respectively. Individual numerical values in the dataset are transformed into colors for representation. Columns and rows are clustered by similarity, w

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  • Case Study: Regulatory and Safety Support for Phase 2 Portfolio

    Posted on 7/15/2014 4:12 PM

    Challenge: Support Large Pharmaceutical striving to enhance Neuroscience Phase 2 portfolio A large pharmaceutical company looking for innovative ways to enhance their Neuroscience Phase 2 portfolio and service delivery speed, created a new division with the intent to offer more flexibility to the team managing their portfolio of approximately nine active compounds. The leadership team for the new division realized they needed to partner with a clinical research organization with the operational

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  • Case Study: MMS Support for Entire Women's Health NDA

    Posted on 7/8/2014 4:19 PM

    Challenge: Sponsor Needed NDA Support for Women's Health Compound A small company in partnership with a mid-sized Japanese pharmaceutical company needed full planning, operations and NDA submission support for a women's health compound. The full scope of services included project management, a timeline for all operational tasks and the development of the overall submission. MMS was responsible for preparing the final pivotal CSR and integrated analysis plan, converting and integrating clinica

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