SPECIALTY PHARMA CONSULTING
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  • REGULATORY AFFAIRS

    Navigating the intricacies of global pharmaceutical regulations

    Whether you are seeking to gain regulatory approval for a new drug, ensure compliance with existing regulations, or optimized your regulatory strategy, we are here to help you achieve your goals.
  • US AGENT

    Representing your organization with the US FDA

    At the heart of our company we are committed to excellence in regulatory affairs. We understand that the regulatory environment is constantly evolving and our team can represent your organization as a US Agent with the FDA.
  • OPERATIONAL EXCELLENCE

    Creative programs for your organization

    Support in transforming your pharmaceutical operations into models of excellence. Our dedication to continuous improvement, data-drive decision making, and unwavering commitment to quality will help you achieve and sustain success in this highly regulated and competitive industry.
  • QUALITY ASSURANCE

    Tailored QA services to align with your unique operations

    Whether it be support in quality systems development, audits, inspections, risk management, GxP training, or the fundamentals of batch oversight and release; our firm is founded on a steadfast commitment to delivering QA solutions that exceed industry standards. We understand the critical role QA plays in pharmaceuticals and we are dedicated to helping our clients achieve the highest level of quality in every aspect of their operations.
  • QUALITY ENGINEERING

    Delivering top tier quality engineering solutions

    We recognize the critical role that quality plays in drug development, manufacturing, and distribution. Our subject matter experts assist pharmaceutical, biotech and medical device firms to achieve operational excellence while adhering to stringent regulatory standards.

Our SMEs are seasoned professionals with in-depth knowledge of processes, regulations, and best practices

  • Customized Solutions
    We understand that each operation is unique. We tailor our services to align with your specific needs, ensuring practical and effective solutions within the regulatory, quality and operational space.
    Comprehensive Quality and Regulatory Services
    Elevating your efforts to new heights. Our commitment to quality, regulatory expertise and industry knowledge will empower your company to consistently deliver safe, effective and compliant products.
    Training for the Future
    Dedicating to help you achieve the highest levels of quality, we will conduct thorough internal and supplier audits to create training programs that your employees can understand. Our trainings, are not cookie cutter GxP programs, but created specifically for your organization.
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    Our commitment is to create support services tailored for your organization

Reviews

Feedback from our clients

  • We were really in need of assistance to help us with our last minute regulatory filings for the year. SPC was able to jump in quickly and help support us with all our regulatory needs.
    Jorge Dieter
    (31 December 2021)
    SPC knows regulations for every country. They were my one consulting team to help with all my submission activities around the world. It was a nice way to have all my documents in one management location.
    Ying Li
    (04 April 2022)
  • The GxP training program was very helpful. Our employees understood the requirements very clearly.
    Jun Lee
    (11 June 2023)
    Truly a great group of people to work with. They are my quality, regulatory and Six Sigma/LEAN experts.
    Steven Howard
    (13 April 2023)
  • SPC was great to work with. They listened to my needs and what I had hoped to improve within my process. The results were 100x greater than my hopes. Amazing.
    Theresa S.
    (13 April 2021)
    My organization got a really bad audit from the FDA. I didn't know where to turn, but luckily I hired SPC. Within the next audit we were ready and got approval for our drug and manufacturing facility! Thanks.
    Richard Platt
    (Feb. 13, 2019)
  • We did not know all the FDA requirements for manufacturing when we started our business. SPC helped us develop our facility, equipment, and processes to meet FDA standards. Our audit went very well and they are our US Agent for all activitites.
    Soo Kim
    (04 October 2018)
    Has been our US Agent for a long time. We could not do it without their help!
    Praveen Singh
    (01 July 2019)
  • Took COVID to allow us to make improvements in our processes and facilities. SPC's Operational Excellence team was very helpful. They are definitely the experts.
    Mario Pena
    (21 March 2020)
    The data analysis that SPC QE support did was incredible. The information and improvements that were made for our business could not have been done without their support.
    Niamh Callahan
    (10 October 2021)
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Our subject matter experts are available to you 24/7