Pharmaceutical Regulatory Affairs
Regulatory Affairs Senior Consultant
Scientific rigour and strategic clarity,
in service of programs that matter.
About
Silvia is a motivated, curious, and pragmatic Regulatory Affairs Consultant with over ten years of experience in the field, primarily focusing on development-stage programs, with strong experience in start-ups and Small and medium-sized enterprises (SMEs). Through direct and repeated interactions with Health Authorities and hands-on preparation of regulatory dossiers, she has developed a strategic mindset that allows her to support pharmaceutical and biotech companies in defining clear regulatory goals for their investigational products, from Phase I through to MAA.
Her mission is to be a flexible and integrated regulatory partner — adapting to each team's unique structure and providing the strategic and operational support needed, exactly when it is needed. From nonclinical development through late-phase clinical trials, her goal is to fill the gaps seamlessly and help clients advance their medicinal products with confidence.
For investors, this same depth of experience translates into something equally valuable: the ability to read a regulatory package critically — to identify what is solid, what is optimistic, and what carries real risk to timelines and value. Having supported due diligence processes from both sides — as regulatory advisor to companies under scrutiny and to those conducting assessments on third-party assets — Silvia understands the regulatory signals that matter most before a deal is closed.
Service Area I
Early-stage companies face their most consequential regulatory decisions with the least internal resource. I provide the strategic guidance and hands-on support to navigate that phase with confidence — with the agility and focus that only an independent expert can offer.
Design and critical review of clinical development programmes aligned with EMA and FDA expectations — from Phase I strategy through Phase III design, structured to support regulatory approval and investor milestones.
Assessment and planning of the preclinical packages required to support first-in-human studies and each successive phase of clinical development. Identification of data gaps before they become regulatory obstacles or clinical hold risks.
Preparation and strategic support for Scientific Advice and other key regulatory meetings with health authorities. Direct experience negotiating with EMA, FDA, AIFA and EU national competent authorities.
Orphan Drug Designation, PRIME, Fast Track, Breakthrough Therapy Designation, Paediatric Investigation Plans (PIPs & iPSPs). Securing regulatory advantages from early development onwards.
CTAs (including CTIS), INDs, IBs, IMPDs and amendment management. End-to-end coordination across clinical, non-clinical and CMC functions to deliver complete, consistent regulatory packages on time.
Strategic and operational support in the transition from clinical studies to Marketing Authorisation Application (MAA), with a focus on preclinical and clinical data robustness.
I support project due diligence by assessing the product's development stage, identifying potential regulatory hurdles, outlining additional requirements, and estimating timelines for submission and approval of a MAA.
I offer tailored training courses on a wide range of EU regulatory affairs topics designed to support SMEs lacking in-house expertise, as well as larger companies seeking to equip staff with the necessary regulatory knowledge.
Service Area II
Before committing capital to a life science asset, you need an independent expert who can read the regulatory package critically — identifying what is solid, what is overstated, and where the real risks to timelines and value lie.
In 2024, venture capital invested $26 billion across 416 life science rounds, and biopharma M&A reached $49 billion across 91 transactions (J.P. Morgan). Behind the most successful deals sits a shared discipline: regulatory due diligence that identifies the right risks early — enabling better deal terms, more accurate valuations, and decisions made with real confidence.
Independent evaluation of the regulatory risks in a target company's development programme — pathway viability, precedent analysis, labelling risk — before they surface in agency interactions.
Critical appraisal of data packages: are the endpoints appropriate and precedented? Are the comparators defensible? Is the safety database adequate to support the next regulatory step?
Assessment of whether proposed milestones and timelines are regulatory-feasible. Quantification of hidden delays and their impact on valuation assumptions and deal structure.
Interpretation of prior Scientific Advice outcomes, agency feedback letters, and regulatory correspondence — the clearest signal available of where a programme truly stands with regulators.
A concise, structured expert opinion on the regulatory profile of a target asset — designed for investment committees and formatted to inform deal decisions with clarity.
Background
Career
Insights
Contact
Whether you are a pharmaceutical or biotech company navigating a regulatory challenge, or an investor assessing a life science asset, I welcome focused, confidential conversations about how I can support your objectives.
