Comprehensive Pharma Regulatory Consulting and Life Sciences Support
The a4SU program provides startups and scaleups with comprehensive support at competitive rates, with special emphasis on healthcare and life sciences ventures navigating complex regulatory and commercial landscapes. Our specialized services integrate all our capabilities with specific expertise.
We help pharmaceutical and medical device companies navigate from concept through commercialization with guidance on regulatory strategy, market access, competitive intelligence, and commercial execution. This isn’t generic consulting adapted to healthcare; it’s pharmaceutical expertise applied to startup and scaleup challenges.
For ventures where regulatory approval is just the beginning of commercial complexity, integrated support across legal, financial, regulatory, and commercial functions accelerates time to market and maximizes commercial potential.;
Regulatory Strategy & Compliance
Definition of regulatory strategy in countries of interest according to company needs, applicable laws, and regulatory requirements. Revision of product documentation and promotional materials, labeling, batch records, product specifications, and test methods for compliance with required standards.
Our pharma regulatory compliance expertise spans EMA, FDA, and Swissmedic pathways. We provide end-to-end regulatory lifecycle management from due diligence through post-approval variations, enabling smooth progression from development through approval.
Commercial Partnerships
Research and identification of potential business partners, drafting and negotiating relevant agreements. We leverage extensive networks to identify distribution partners, co-promotion opportunities, regional licensing candidates, and strategic collaborators across therapeutic areas.
Our pharmaceutical background enables realistic partner capability assessment and win-win agreement structuring that balances risk and reward appropriately.
New Product Development
Portfolio candidates identification and selection, product sales forecasts and NPV models, pharmaceutical product development and life cycle management strategy. We help prioritize pipeline investments based on commercial potential integrated with scientific merit.
Our approach accounts for regulatory pathways, competitive landscapes, pricing potential, and reimbursement probability, producing forecasts that guide resource allocation realistically.
Market Analysis & Intelligence
Existing portfolio strategy evaluation, assets evaluation and LCM strategy, therapy areas and franchise strategy, competitors analysis, differentiation strategy. We provide healthcare competitive intelligence that goes beyond surface analysis to understand prescriber behavior, payer dynamics, and patient pathways.
For competitive intelligence, we track competitor pipelines, pricing strategies, market access approaches, and promotional tactics, identifying opportunities and threats systematically.
Market Access & Pricing
Burden of Illness (BOI) analysis, definition of market access and pricing & reimbursement (P&R) strategy, integration of market access needs within clinical development programs, product value element definition, and development of market access key tools including core value dossiers and economic models.
We develop health technology assessment and P&R strategies that demonstrate value to payers while supporting sustainable pricing. Our real-world evidence capabilities strengthen value propositions with post-launch data.
Internal SOPs & Quality Systems
Issuance, revision, and operational implementation of internal SOPs for correct management of business activity in compliance with pharmaceutical regulations. We create practical quality management systems, regulatory submission procedures, pharmacovigilance protocols, adverse event reporting workflows, and record retention systems.
Our SOPs satisfy regulatory inspectors while remaining operationally usable, bridging the gap between compliance requirements and daily operations.
Pierfrancesco brings 30+ years of leadership experience with strong track record in market access, business development, and evidence-based value communication. His expertise spans pricing and reimbursement, health economics and outcomes research (HEOR), licensing, regulatory affairs, medical affairs, and digital therapeutics.
A recognized thought leader, Pierfrancesco has authored numerous publications on clinical and economic value of health technologies and brings deep expertise in real-world evidence (RWE) generation and real-world data (RWD) strategies.
Regulatory Expertise Through Our Network
For pharma regulatory consulting and compliance needs, we work with senior regulatory professionals bringing 20+ years expertise across EMA, FDA, and Swissmedic pathways. Our network specialists coordinate submission teams, support manufacturing operations, and actively contribute to GMP, GCP, and pharmacovigilance inspections.
Team Integration
Healthcare & Lifescience projects benefit from integrated expertise: Pierfrancesco Ruffo leads market access and commercial strategy, Andrea Meoli drives business development, Hans Schmid structures financial partnerships, and Gaetano Biondo executes marketing strategies. When needed, we leverage specialized professionals for IP strategy and licensing agreements across multiple jurisdictions.