Strategic Advice
Early, cross-functional guidance that shapes your development plan before resources are committed. That covers defining the (regulatory) pathway, framing the right questions for authorities, assessing the risks in an existing program, and building a development roadmap that connects science, regulation, and market access. When the strategy is set, we then also help to execute it.
Examples of How We Support
These are just examples to illustrate the kind of work we do day to day. The fastest way is usually a short call to understand your situation and discuss how we can help.
Early-stage pathway assessment
You have a promising compound or product concept and need to understand what it will take to get it approved. Classification, medicinal product, device, combination, borderline, target product profile, regulatory pathway options, orphan and paediatric, EU HTA impact, requirements, all need to be assessed before you commit resources.
Cross-regional filing strategy
You're planning to file in multiple regions and need a coherent cross-regional strategy. EU, US, Japan, or other markets have divergent requirements, and you need a roadmap that sequences scientific advice, clinical trial applications, and marketing authorisations without conflicts or wasted effort.
Operational setup for launch
You're preparing to launch and need clarity on the licences and authorisations required to operate legally across your target markets. Manufacturing and importation authorisations (MIAs), wholesale distribution authorisations (WDAs), and other entity-level licences must be in place and aligned with your supply chain model. We help define what is required, when to apply, and how to structure your operations to ensure compliance without delaying launch.
Scientific advice preparation
You need to prepare for scientific advice, a parallel EMA/FDA advice, or a parallel EMA/HTA consultation and want to make sure you're asking the right questions at the right time, with a briefing package that positions your program effectively.
Asset due diligence
You're evaluating an asset for licensing, acquisition, or investment and need an independent regulatory gap analysis: what's in the dossier, what's missing, what the risks are, and what it will take to close the gaps.
Program course correction
Your development program has hit an inflection point. A study didn't deliver the expected results, a competitor has changed the landscape, or a regulatory change, EU AI Act, new HTA requirements, MDR transition, has shifted the ground under your strategy. You need a revised plan.
Understanding Strategic Advice
Strategic advice is the “what” and “when” of your regulatory approach: which pathway, which procedure, which interactions with authorities, in what sequence, and with what evidence. It’s distinct from the operational execution that follows (writing the dossier, compiling the CTD, managing submissions), which is covered on the Regulatory Strategy & Operations page.
That said, strategy and execution are not separate engagements at regenold. We design the strategy with the intention of executing it. When we build a regulatory roadmap, we’re also the team that writes the briefing documents, compiles the dossier, and manages the authority interactions. This means the strategy is grounded in what’s actually deliverable, not in theoretical recommendations.
What We Do
Strategic advice touches every function in a development programme. Here’s what we deliver in practice:
Our Workstreams
We structure strategic advice around five domains. Most engagements touch more than one.
Regulatory Feasibility & Pathway
Target product profile definition. Classification assessment (medicinal vs. device vs. borderline). Orphan, paediatric, PRIME, and RMAT eligibility evaluation. Authorisation route selection (CP, DCP, MRP, national).
Cross‑Regional Strategy & Roadmapping
EU/US/Japan/global regulatory roadmaps. Alignment of submission timelines across regions. Synchronised scientific advice and HTA engagement planning. Market access considerations integrated into regulatory sequencing.
Scientific & HTA Advice Planning
Question framing and briefing document preparation. EMA Scientific Advice, Innovation Task Force, FDA Pre-IND, MHRA Innovation Office, and national agency meeting coordination. Parallel EMA/HTA scientific consultations (JSC). Meeting rehearsal and post-meeting follow-through.
Due Diligence & Gap Analysis
Regulatory history and dossier review for M&A, licensing, or investment decisions. Risk mapping and gap identification against current regulatory expectations. Remediation planning with cost and timeline estimates.
Regulatory Intelligence & Risk Management
Monitoring guideline changes and legislative developments. Impact assessment for EU AI Act, MDR/IVDR, EU HTA Regulation, and ICH revisions. Strategy updates and contingency planning.
Where This Fits in the Development Journey
Strategic advice is most impactful early, but the need for it recurs at every point where the plan must be reassessed or the regulatory landscape shifts.
Discovery & Concept
Assess feasibility, define target product profile, outline regulatory pathway options, and identify orphan, PRIME, or innovation designation opportunities.
Preclinical
Advise on nonclinical programme design aligned with regulatory expectations. Schedule early scientific advice. Integrate CMC and clinical planning into the regulatory roadmap.
Design & Development
Refine strategy based on emerging data. Coordinate scientific advice and parallel EMA/HTA consultations (JSC). Align CMC, clinical, and regulatory plans with the chosen authorisation pathway.
Clinical
Update strategy in light of clinical findings. Advise on protocol amendments and submission sequencing. Plan HTA engagement for products in JCA scope.
Regulatory Submission & Approval
Finalise strategic narrative for the submission. Advise on paediatric waivers, conditional approvals, or accelerated assessment eligibility. Plan post-approval commitments.
Launch & Market Access
Align regulatory strategy with pricing, reimbursement, and market entry plans. Support HTA submission strategy, including JCA-readiness for applicable products.
Post-Market & Lifecycle Management
Revisit strategy for new indications, variations, or market expansion. Plan lifecycle management in response to safety signals, competitor developments, or regulatory changes.
Product Type Considerations
The strategic questions change depending on what you’re developing. Here are the key differences by product type:
Small Molecules
Focus on nonclinical-to-clinical translation, impurity control strategy, and bridging or bioequivalence approaches for generics or repurposed products. Filing route choice (centralised vs. national) often depends on therapeutic area and commercial strategy.
Medical Devices & IVDs
Classification under MDR (Annex VIII) and IVDR, including borderline and novel device types where the classification pathway is not straightforward. Notified Body strategy: selection, capacity assessment, and planning for the conformity assessment route (Annex IX vs. Annex XI). For companies still completing the IVDR transition for legacy IVDs, strategic planning for transition timelines and regulatory priorities. From 2026, selected high-risk devices fall within scope of Joint Clinical Assessments (JCA) under the EU HTA Regulation. We advise on the regulatory and evidence implications.
Combination Products
Primary mode of action determines the lead regulatory framework. Planning for Article 117 submissions, device-quality documentation integration, and coordinated regulatory and HTA strategy across both product components.
Biologics & ATMPs
Comparability planning, vector or cell-source considerations, and eligibility for PRIME or RMAT designations. Early scientific advice is often critical to align on nonclinical models and potency assays.
Digital Health & SaMD
Classification as medical device vs. wellness product. MDR/IVDR compliance, EU AI Act obligations, and clinical evidence strategy. Regulatory approach must integrate software development lifecycles with clinical validation.
Sample Deliverables
Regulatory strategy memorandum: classification, authorisation route, orphan/paediatric opportunities, and key development considerations. 
Cross-regional development roadmap linking nonclinical, CMC, clinical, and regulatory milestones with proposed timing for authority interactions. 
Scientific advice briefing package: background, questions, and justifications for EMA, FDA, or national agency meetings, plus rehearsal agenda. 
Parallel EMA/HTACG consultation (JSC) preparation: aligned regulatory, clinical and HTA question sets, evidence gap analysis, and PICO-readiness assessment. 
Parallel EMA/FDA scientific advice: assessment of the overall development plan, aligned set of questions and company positions according to EMA and FDA standards, procedure management, and a post-advice action plan covering both geographies. 
Regulatory due diligence report: detailed analysis of existing data and documentation, gap identification, risk assessment, and remediation recommendations. Regulatory risk register: rolling log of regulatory changes and their impact on your programme, with recommended actions. Example Projects
Illustrative Example
Gene Therapy Start-up: Regulatory Feasibility From Early Discovery
A small biotech developing a gene therapy engaged us during early discovery. We confirmed ATMP classification, evaluated orphan designation eligibility, and built an EU/US roadmap highlighting the need for early EMA/FDA scientific advice, comparability planning, and GMP vector manufacturing readiness. The strategic plan guided investment decisions and partnership discussions.
Illustrative Example
Mid-size Pharma: Cross-Regional Strategy for a New Small Molecule
A company developing a new small molecule for a rare indication needed a filing strategy. We evaluated centralised eligibility criteria, run a competitor landscape analysis, confirmed orphan eligibility, and recommended the scientific advice approach. The roadmap aligned CMC scale-up and clinical development with regulatory timelines and identified early HTA engagement opportunities.
Illustrative Example
PE-Backed Portfolio Company: Regulatory Due Diligence for Asset Acquisition
A private equity firm needed an independent regulatory assessment of a late-stage asset before completing an acquisition. We reviewed the existing dossier, identified gaps in the CMC and clinical data packages relative to current EMA expectations, quantified the remediation effort, and provided a risk-adjusted timeline to MAA. The assessment informed the deal valuation and post-acquisition development plan.
Defining a Regulatory Pathway, Preparing for Scientific Advice, or Evaluating an Asset?
Tell us about your product and where you are in the process, and we’ll outline how we can help.
Speak with an ExpertKey Regulations & Guidance
These frameworks most frequently inform our strategic advice work:
Frequently Asked Questions (FAQ)
What is the difference between strategic advice and operational regulatory support?
Strategic advice defines the direction: which pathway, which interactions with authorities, in what sequence, and with what evidence. Operational support executes the plan: writing CTDs, publishing eCTD packages, managing submissions, and handling authority correspondence. At Regenold, the same team often does both, which means the strategy is designed to be executable from day one.
How is strategic advice different from EMA scientific advice?
EMA scientific advice is a formal interaction where a regulatory authority responds to specific questions about your development plan (study design, endpoints, methodology). Our strategic advice prepares you for those interactions: it determines when to request scientific advice, frames the right questions, prepares the briefing documents, and integrates the authority's feedback into the broader development strategy. We provide strategic advice to make sure your scientific advice is productive.
Do you also advise on HTA strategy?
Yes, and the timelines are now critical. The EU HTA Regulation (EU 2021/2282) has been fully operational since January 2025. Joint Clinical Assessments (JCAs) currently apply to oncology products with new active substances and ATMPs. From 2026, JCAs will extend to selected high-risk medical devices (approximately 5 planned, starting June 2026). Orphan medicines follow in 2028, and all new medicinal products eligible for centralized procedure in 2030. We work with dedicated HTA partners to assess JCA readiness, align regulatory and payer evidence, and support joint EMA/HTACG scientific consultations.
When should we seek strategic regulatory advice?
Before you make irreversible commitments: choosing a regulatory pathway, designing a pivotal study, selecting a manufacturing approach, or filing in a specific market. The earlier you align your development plan with regulatory expectations, the lower the risk of costly rework or misaligned data packages.
Can you help with borderline product classification?
Yes. Products at the interface of medicinal, device, cosmetic, or food regulation require careful assessment of primary mode of action against the relevant legislative definitions. We evaluate the regulatory landscape, prepare classification dossiers with supporting evidence, and engage with competent authorities where the classification is contested.
How do you handle regulatory due diligence for investors?
We review the existing regulatory, development, and compliance documentation, assess it against current authority expectations, identify gaps and risks, and produce a decision-ready report with remediation timelines and cost estimates. For broader DD (CMC, clinical, commercial), see Due Diligence Support.
Do you provide strategic advice for medical device programmes?
Yes. Device programmes raise distinct strategic questions: MDR/IVDR classification for novel or borderline products, Notified Body selection and capacity, conformity assessment route decisions, IVDR transition planning for legacy IVDs, and evidence strategy for clinical evaluation. We also advise on the EU HTA Regulation implications for high-risk devices entering JCA scope from 2026. For the hands-on conformity assessment and technical documentation work, see Medical Device Regulatory Services.