Regulatory Open Forum

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  • 1.  Looking for Suggestions to Handle Growth

    Posted 14-Apr-2016 10:09

    Dear RA Colleagues,

    I work for a rapidly growing pharmaceutical company. We are developing and acquiring products on a regular basis. The issues that come with the growth is great. However, we currently have a very small staff and I want to know if you have any consultant recommendations for someone who can come in and look at our staffing, systems and processes. Subsequently make recommendations for changes using their experience and best practices.

    Thank you,

    Eric

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    Eric White
    Mission Pharmacal Company
    Boerne TX
    United States
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  • 2.  RE: Looking for Suggestions to Handle Growth

    Posted 14-Apr-2016 10:52
    Hi Eric,

    As a seminar speaker/trainer, I advocate "Total Control of Compliance."

    As an auditor, I point out potential objectionable conditions (e.g., non-conformance) in view of the the applicable GMP requirements to your firm.

    As a consultant, I provide guidance and direction on what to address, further to improve or to fill in the gaps in view of the applicable GMP requirements.

    You may consider our services as a trainer, auditor, and/or consultant.

    Thank you.  

    s/ David
    ______________________________________________
    Dr. David Lim, Ph.D., RAC, ASQ-CQA 
    Phone (Toll-Free): 1-(800) 321-8567



    "Knowledge is power only when it is practiced and put into action." - Regulatory Doctor

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    Original Message


  • 3.  RE: Looking for Suggestions to Handle Growth

    Posted 15-Apr-2016 08:39

    Dear Eric,

    This type of thing is right up our alley. We are the leader in global regulatory affairs consulting. We handle all kinds of projects big and small.

    We'd be delighted to help you with your happy problem of rapid growth.

    We can review your processes and systems, offer our insights on how and when to bring in new staff, or provide hands and project mangers onsite or remotely to temporarily help you manage the regulatory requirements of an influx of new products. We are well-steeped in Lean Six Sigma practices to help optimize workflows and processes, bringing you best-in-class solutions.

    Hope we can be of assistance to you.

    Global Regulatory Affairs Leader | GENPACT Pharmalink

    Pharmalinkconsulting remove preview
    Global Regulatory Affairs Leader | GENPACT Pharmalink
    Pharmalink Consulting is the leader in global regulatory affairs working across the major healthcare sectors
    View this on Pharmalinkconsulting >
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    Heather Hammond
    Senior Manger, Global Regulatory Affairs
    Genpact Pharmalink

    Original Message