Achieve Regulatory Excellence with Expert Insights & Consulting

Regulatory Strategy

Understanding the regulatory strategy for an exploratory product is a critical success factor in its development. Quantum experts help clients in navigating key regulatory challenges, including authority engagement, evolving regulations, possible options for accelerating development, and additional data exclusivity.

Our regulatory team provides leadership throughout the project life cycle, collaborating with development teams at every stage.

Comprehensive strategic planning from pre-clinical stages and Initial INDs to NDA/BLA filing and post-market life-cycle maintenance/expansion
Critical program review and regulatory issue analysis
Due diligence and strategic business support regarding licensing and investment decision making
Regulatory risk analysis and mitigation strategy planning
Expert consulting on key regulatory scientific topics such as QT prolongation, suicidality assessment, abuse potential
Rare disease considerations and pediatric drug development strategies
Indication and population expansion in the post-approval setting

Health Authority Liasion & Meeting Support

With extensive experience in regulatory authority interactions, the Quantum team excels in building and maintaining effective relationships with agency staff at all levels. These connections guide companies through the complexities of the regulatory maze.

Having led hundreds of regulatory authority liaison activities, including FDA Pre-IND, End of Phase 2, and Pre-NDA/BLA meetings, Label negotiations, FDA Advisory Committees, European national regulatory interactions, and CHMP meetings, our team is highly skilled in preparing for and executing successful regulatory authority meetings and interactions.

Pre-IND, End of Phase 2, pre-NDA/BLA, Advisory Committee
Meeting planning and execution
Preparation and submission of meeting request
Preparation and submission of briefing document
Rehearsals and team preparation
Conduct of meeting and follow up
Ad hoc consulting on specific components
Briefing document review
Assessment of questions for FDA
Participation in “mock” meetings

eCTD Publishing & Submissions

The 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.

To ensure optimal security and compliance, our team has a robust infrastructure for electronic document management and the processes to ensure clear communication between regulators and sponsors.

Regulatory document level publishing for INDs, CTAs, NDAs, MAAs
Preparation and submission of pre-INDs documents and initial IND
Expert consulting on CTD build for US NDAs and EU MAAs
Maintenance of existing INDs, CTAs, NDAs, and BLAs

Medical Writing

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 including:

Our regulatory experts are poised to help you prepare:

Document formatting and editing (consistent styles, headers/footers, tables of contents, etc.)
Investigational New Drug Applications (INDs) and Marketing Authorizations
Clinical Study Protocols
Investigator Brochures
Investigational Medicinal Product Dossiers (IMPDs)
Patient Information Sheets (PIS) and Informed Consent Forms (ICF)
Integrated Summaries of Efficacy and Safety (ISE and ISS)

Regulatory Chemistry, Manufacturing, & Controls (CMC)

Quantum has experts for every type of project: small molecules, devices, biologics, cell therapy and gene therapy. Our comprehensive regulatory CMC services include both strategic and operational aspects:

Our comprehensive regulatory CMC services include both strategic and operational aspects:

Development planning and requirements at various stages of development
Control strategy
Oversight of contract manufacturer activities
Writing of quality documents for Module 2.3 and 3
Tech Transfer and scale up oversight and advising
Post-market change control evaluation and strategy development

Labeling-Ad Promo

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. This is why we provide experienced labeling support from pre-INDs projects through post-marketing.

Our experienced consultants will support you in developing core and local labeling and artwork and will ensure your company does not run afoul of current regulations and guidances with your advertising and promotional materials:

Target Product Profile development
Competitor analysis
Critical review of advertising and promotional materials for pre-launch activities or for marketed products
Core and local labeling development
Commercial label and artwork development
Label and artwork compliance management
Management of cross-functional labeling and/or ad/promo committee meetings

Regulatory Project Management

Quantum has specialized Regulatory project managers that understand all of the moving parts of a marketing application and all of the inter-dependencies between sections. We can provide leadership and oversight to this complex and business-critical process.

Expert Regulatory Consulting to Navigate the Complex