Regulatory Consulting for Quantifiable Results

Expert guidance throughout the drug development and submission process, ensuring compliance, expediting approvals, and driving success for pharmaceutical, biotech, and biologic companies.

Experience and Expertise You Can Trust

Quantum Regulatory Solutions (Quantum) provides regulatory support to pharmaceutical companies, ranging from start-up to large multinational corporations. We are founded and led by three industry veterans with over 75 combined years of pharmaceutical Regulatory Affairs experience. Collectively, our team has filed 140+ marketing authorizations and launched over 100 products in the United States.

We work collaboratively with our clients at all stages of development through innovative, customized strategic programs to help them obtain and maintain regulatory applications necessary to study investigational drugs, devices, biologics and advanced therapies. Our team can “hit the ground running” to make immediate, valuable contributions with Strategy, Meeting Support and Agency Liaison, Regulatory Project Management, CMC, Ad/Promo, Labeling, and Medical Writing.

Complete Life-Cycle Regulatory Support

Quantum has experts to support your projects at any stage of development or approval.

  • Early stage development requires extensive expertise around pre-clinical and toxicological considerations. Our network of consultants allows for one stop shopping, including specific non-clinical medical writing support, to expedite your project to the First in Human stage.

  • Peri-approval activities are critical to ensure a timely product approval and market launch. Quantum can help ensure filing expectation alignment with Regulatory Authorities through pre-marketing authorization submission meetings, timely and complete submissions of marketing authorization applications, planning for and support of queries during review, and providing advice and perspective during negotiations for approval, as well as, post approval commitments.

  • Post-approval compliance. Because product activities don’t stop after approval, we have specific experts to support required submissions to ensure your product remains compliant. Change control assessments, labeling updates, annual reports and ad/promo reviews and submissions are just a few areas where Quantum can support and streamline your ongoing product maintenance requirements.

Types of Regulatory Support

  • Ad hoc - Whether you need 1 hour per month or 15 hours per week, Quantum can support your needs, if and when you have the demand. Hourly billing ensures you only get charged when our strategists are actively supporting your work. The Quantum team can provide consistent support as your business needs ebb and flow.

  • Full Time Equivalent (FTE) - Quantum has an extensive pool of highly qualified Regulatory Strategists to fill resource “gaps” at mid-size and large pharmaceutical companies. We have successfully delivered services to multiple “top 10” companies, all of which have been long-term repeat customers. We provide skilled strategists to support both marketed products and development activities. In most cases, our strategists have been designated as the US, EU or Global Regulatory Leader for their assigned compounds.

    It is critically important to provide a resource that is a proper company cultural and working style “fit” in these situations. Generally, these strategists work remotely but within the client’s infrastructure (Regulatory Operations functions, Document Management systems, proprietary regulatory systems, etc).

Services That Deliver Impact

Successfully navigating the complex regulatory landscape takes deep experience and expertise. Explore our services to see how our Regulatory Experts can help you reach your next milestone.

Areas of Expertise

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Product Types

Quantum has experience in supporting all product types, including:

  • Small molecules

  • Biologics

  • Cell & gene therapies

  • Combination products

  • Stand alone devices

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Therapeutic Areas

  • Infectious Diseases

  • Inflammation

  • Neurology

  • Oncology

  • Pain

  • Psychiatry

  • Rare Diseases

Our consultants have broad expertise in most therapeutic areas, with extensive experience in:

  • Addiction

  • Cardiovascular

  • Critical Care

  • Dermatology

  • Endocrinology

  • Hematology

  • Immunology

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Clinical Trial Applications & Marketing Applications

Quantum is experienced in helping sponsors file:

  • INDs

  • NDAs

  • BLAs

  • 505b2s

  • ANDAs

  • European MAAs (various pathways)

Get in Touch

Need immediate, valuable contributions of Strategy, Meeting Support and Agency Liaison, Regulatory Project Management, CMC, Ad/Promo, Labeling, and Medical Writing?