QUANTIFIABLE RESULTS

EXPERIENCE + EXPERTISE

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 over 140 marketing authorizations and launched over 100 products in the United States.

We work collaboratively with our pharma 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.

AREAS OF EXPERTISE

Therapeutic Areas

Quantum consultants have broad expertise supporting development of products in most therapeutic areas, with extensive experience in:

  • Addiction

  • Cardiovascular

  • Critical Care

  • Dermatology

  • Endocrinology

  • Hematology

  • Immunology

  • Infectious Diseases

  • Inflammation

  • Neurology

  • Oncology

  • Pain

  • Psychiatry

  • Rare Diseases

Product Types

Quantum has experience in supporting all product types including: small molecules, biologics, cell/gene therapy, combination products, and stand alone devices.

Clinical Trial Applications and Marketing Authorizations

Quantum has experience and can assist you with filing: INDs, NDAs, BLAs, 505b2s, ANDAs, and European MAAs (various pathways)

Services

  • Understanding the regulatory strategy for an exploratory product is a critical success factor in its development. Quantum Regulatory Solutions’ staff can assist clients in analyzing key regulatory issues and navigating the complex path through development. Learn more.

  • Through experience of countless regulatory authority interactions, the Quantum Regulatory Solutions’ staff each has a detailed understanding of building and maintaining effective relationships with regulatory agency staff at all levels. These relationships can help a company navigate a clear path through the daunting regulatory maze. Learn more.

  • Quantum Regulatory Solutions’ team has made hundreds of submissions to regulatory authorities, ranging from routine IND updates to full-blown marketing applications in the US and EU. We understand the vital importance of high-quality documentation and submissions that are compliant with eCTD standards and the value of a customer-focused approach to regulatory applications. Learn more.

  • The success of regulatory submissions and the conduct of a clinical trial can be greatly influenced by the quality and clarity of the documents supporting it. Quantum has experienced medical and scientific writers who can provide high quality non-clinical, clinical and quality documents to support your regulatory submissions. Learn more.

  • Quantum has experts for every type of project: small molecules, devices, biologics, cell therapy and gene therapy. Comprehensive regulatory CMC services including both strategic and operational aspects. Learn more.

  • At Quantum, labeling is never seen as a topic that is only related to marketing of an approved product. Good development planning includes consideration of the desired commercial label from the earliest stages. Learn more.

Complete Life-Cycle 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 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). 

Get in Touch

Reach out to Quantum Regulatory Solutions when you need immediate, valuable contributions with Strategy, Meeting Support and Agency Liaison, Regulatory Project Management, CMC, Ad/Promo, Labeling, and Medical Writing.