pharmaceutical regulatory affairs

At ADRES, we help clients translate scientific innovation into a clear regulatory plan that supports business goals, investor discussions, clinical execution, and long-term market access. Whether the product is a small molecule, biologic, advanced therapy medicinal product (Cell and Gene Therapy), combination product, or medical device, we define the pathway in a way that is realistic, evidence-based, and commercially aware.

Our work often begins with foundational questions:

• What is the right regulatory pathway in the US, EU, Israel, or other target markets?
• How should the product be classified and positioned?
• What data package is needed at the current stage?
• Which agency interactions are worth pursuing now?
• Where are the major regulatory, CMC, preclinical, or clinical risks?
• Which designations or expedited pathways could strengthen the program?

That last point matters more than many early-stage companies realize. For selected rare disease programs, orphan planning should be considered as part of the broader regulatory strategy, not as a separate administrative exercise. In the US, this may include Orphan Drug Designation (ODD) with the FDA. In Europe, it may include Orphan Medicinal Product Designation (OMPD) through the EMA framework. These pathways have specific criteria and strategic implications, so they need to be integrated thoughtfully into the wider development plan. (European Medicines Agency (EMA))

What we do

Regulatory strategy and pathway planning

We develop regulatory strategies for drug, biologic, and medical device development across major markets. This includes defining the regulatory route, aligning development plans with agency expectations, evaluating evidence gaps, and prioritizing actions that will matter later during submissions and review.

Health authority interaction support

We prepare companies for meaningful engagement with regulators and notified bodies. We support scientific advice meetings, pre-IND meetings, end-of-phase two meetings, classification discussions, briefing packages, meeting strategy, and follow-up communication.

Submission planning and dossier support

We support the preparation, review, and submission of regulatory documentation across development stages. This includes documents such as INDs, IMPDs, briefing books, pediatric plans, scientific justifications, technical files, and other core regulatory packages needed to move programs forward.

Designation and special pathway support

We advise on regulatory opportunities that may accelerate development, reduce uncertainty, or strengthen the product’s positioning. Depending on the program, this may include support for orphan designation strategy, orphan designation request packages, pediatric planning, expedited pathway positioning, and other designation-related activities.

For rare disease products, we help clients assess whether orphan designation is strategically justified, whether the scientific rationale is strong enough, and how to build a defensible regulatory narrative for FDA and EU submissions. Both the FDA and the EMA describe orphan designation as a separate process from product approval that may provide incentives including fee exemptions, tax credits for qualified clinical testing, and the potential for seven years of market exclusivity after approval. In the EU, orphan designation is reviewed against criteria including disease severity, rarity, and significant benefit where relevant. (U.S. Food and Drug Administration)

Gap assessments and development readiness

We conduct regulatory, clinical, CMC, and nonclinical gap assessments to identify weaknesses before they become expensive problems. This is especially valuable before financing rounds, major authority interactions, pivotal studies, or formal submissions.

Regulatory input across development

Regulatory decisions affect more than regulatory documents. We provide ongoing input into indication selection, development sequencing, study planning, manufacturing considerations, evidence generation, and cross-functional decision making so the regulatory strategy remains practical and aligned with execution.

Support across the product lifecycle

ADRES provides regulatory affairs support across all stages of development:

• Early stage: product classification, regulatory pathway definition, indication assessment, early risk mapping, orphan designation feasibility, and initial agency strategy
• Preclinical stage: regulatory roadmap refinement, nonclinical planning support, briefing package development, and data gap assessment
• Clinical stage: authority interactions, protocol and development alignment, designation support, regulatory writing, and submission planning
• Registration stage: dossier strategy, submission coordination, authority responses, and final readiness support
• Post-approval and market stage: lifecycle regulatory support, change strategy, ongoing authority communication, and market maintenance activities

Regulatory Affairs	Early Stage	Pre-clinical	Clinical	Registration	Market
Regulatory Strategy Develop a regulatory strategy for drug development and approval in European, US, Israel and Rest of the World (ROW)
Manage interactions with regulatory authorities, balancing client’s strategy and regulatory authorities’ expectations
Initiate and perform consultation meetings with regulatory authorities and Notified Bodies, (e.g. scientific advice meetings, pre-IND, EOP2, etc.) throughout the product development lifecycle
Prepare and submit regulatory documents, (e.g., IND, IMPD, BLA, MAA, RFD, Technical File, Orphan Designation, Pediatric Plan, expedite programs designations as PRIME and Breakthrough and more)
Consult on clinical trial design and interpretation.
Writing and Compilation of clinical study documentation (e.g., IB, clinical protocol CSR, etc.)
Regulatory, CMC, Pre-clinical and Clinical Gap assessment
Indication assessment for the potential drug in development from a scientific and regulatory perspective
Planning Non-clinical program including study design and interpretation
Product classification according to regulations and classification submissions
Provide regulatory input to manufacturing and control processes requirements

Where ADRES adds value

Many companies do not fail because the science is weak. They lose time because the regulatory path was oversimplified, the wrong questions were asked too late, or critical activities were handled in isolation.

ADRES brings structure to that complexity.

We help clients:

• make better regulatory decisions earlier
• reduce avoidable delays and rework
• connect regulatory strategy with CMC, quality, and clinical execution
• communicate more effectively with agencies
• strengthen investor and partner confidence through clearer development logic
• prepare higher-quality submissions with fewer surprises

For startups, this often means acting as the regulatory function before a full internal team is built. For established companies, it often means adding senior expertise at critical moments when timelines, submissions, or agency interactions carry high stakes.

Why clients involve us early

The best time to strengthen regulatory strategy is before a major milestone, not after a deficiency letter, delayed meeting outcome, or misaligned study design.

Early ADRES involvement can help with:

• choosing the right indication and sequence of development
• identifying whether orphan positioning is worth pursuing
• aligning regulatory and clinical plans before study execution
• reducing submission risk through targeted gap assessment
• framing agency questions in a way that supports decision making
• building a development narrative that stands up to internal and external scrutiny

This is particularly important in rare disease and innovation-driven programs, where small strategic choices can have outsized effects on designation opportunities, study design, and long-term product value. (European Medicines Agency (EMA))

Our regulatory affairs services include

• Regulatory strategy for the US, EU, Israel, and global markets
• Product classification and regulatory pathway assessment
• Health authority interaction planning and support
• Scientific advice and pre-submission meeting preparation
• IND, IMPD, and other submission support
• Orphan Drug Designation and Orphan Medicinal Product Designation support
• Pediatric and expedited pathway planning
• Indication assessment from a regulatory and scientific perspective
• Regulatory, CMC, preclinical, and clinical gap assessments
• Nonclinical program planning support
• Cross-functional regulatory input throughout development
• Registration and lifecycle regulatory support

Talk to ADRES about your regulatory strategy.