End-to-End Regulatory Strategy, Intelligence, and Business Impact Assessment to Support Development and Commercial Decisions

Regulatory Programme/Project Planning, Governance, and Delivery Leadership for Global Portfolios

Regulatory Dossier Strategy, Gap Analysis, and Lifecycle Management Across Regions

Leadership of Global Regulatory Submissions from Initiation through Approval

Medical and Scientific Writing: manuscripts for peer-review, educational and promotional material (ITA, ENG)

Translation of scientific document from English and Spanish into Italian

Editing of scientific documents

Review and fact-checking of scientific documents

Early-stage drug discovery

Platform positioning

Data management and analysis

Startups

Scientific strategy and project management in life science in general with focus on translational projects in immunology

Consulting on innovative approaches and ideas in biomedical sciences and TechMed. 

Grant writing and funding support

Start-up pitch and value proposition preparation

Drug discovery strategy, including screening cascade, assay design, in vitro pharmacology, IVIV translation, biomarker strategy

Setting up data analysis/management/archiving, LIMS systems for drug discovery

Commercial/BD strategy and pitch deck preparation

Grant, manuscript preparation and review

Medical and scientific writing 

Localization of educational material from English to Italian

Editing and proofreading of medical, scientific, academic, and regulatory documents, fact-checking

Literature search and reference organization

Scientific due diligence for investors 

Expert analysis of pre-clinical data packages for biotech and pharma

Strategic project leadership in early discovery, preclinical and IND-enabling projects

Writing and review of grant proposals and manuscripts

Strategic leadership of early and late phase oncology and rare disease clinical development programmes.

Chartered statistician - specialising in medical statistics, oncology trial design and endpoint management.

Delivery and outcome focussed oversight and management of vendor and sponsor driven clinical trials.

Biomarker and precision medicine, including EU IVDR.

Flow cytometry panel guidance and development

In vitro immunological assay guidance and development (T cells/NK cells/vaccine responses)

QC SOP generation

Clinical operations management

Clinical trial development, study and site management

Vendor/CRO selection, oversight and management

Fractional leadership and KOL advisory

Provide Strategic Vision, Scientific Direction, and Tactical Oversight to Improve and Accelerate Drug Development Journey

Navigate CMC Technical Development Roadmap and Regulatory Landscape

Support CDMO Evaluation and Selection Process

Oversee and Manage Tech Transfer and cGMP Manufacturing Operations

Business strategy for start ups

Quality and regulatory strategy for medtech 

Building executive presence for leaders

Exec coaching for leaders and future leaders

Genome Engineering strategy and production for R&D; expert design of in vivo and cell line models for early-stage drug discovery

Design and implementation of technology platforms including optimisation and miniaturisation for increased throughput

NGS workflow design: set up and troubleshooting automated and scalable RNAseq/DNAseq from bulk, single-cell, or degraded samples 

High-throughput genotype characterisation using qPCR and targeted NGS

Organisation development

Human Resources

Dispute settlement

People Strategy

Regulatory writing (including revision and QC): clinical study protocols, clinical study reports, investigator's brochures, briefing books, CTD

Scientific Writing: drafting/editing/QC of manuscripts for peer-reviewed journals

Strategic business development and innovation management

Strategic copywriting and grant writing for life sciences (websites, LinkedIn, pitch decks, regional/national/EU funding)

Translating research into investor- and industry-ready messaging

Positioning scientists and biotech founders as credible thought leaders

Supporting Start up biotechs in organisation development, R&D Operations

Clinical Operations Leadership and development, CRO Selection and Oversight

Project Management development including Board presentations

Clinical Operations review for Venture Capital Investment

Scientific & Business Strategy

Project Leadership & Management

CRO Scoping & Management

Team Building & Operational Support

Clinical project management

Clinical trial management

Clinical operations management

Study and Vendor oversight

Therapeutic antibody strategies, lead optimisation & engineering

Pre-clinical development, assay design & in vivo models 

R&D management, guidance of in-house & outsourced projects

Scientific & technical writing, data overviews, development plans, and pre-IND dossiers

Alliance Management: contracting CDMOs and managing tech transfer and operations for biopharmaceuticals and cell & gene therapies (ATMPs)

Project & Program Management: managing complex ATMP or biopharmaceutical development programs, technology transfers, and CMC projects to support regulatory filings (IND/IMPD/BLA)

Interim Leadership: stepping in as project director of department head to build and leading teams, ensuring focus and progress

Strategic Support: implementing project portfolio and government frameworks enabling faster decisions, improved accountability and improved alignment across functions and partners

Scaling support from inception to Series A (fundraising, partnership, pathway)

Strategic guidance to refine business models (go to market, IP)

Operational leadership to bridge science and business

Clinical studies and regulatory pathways (FDA, EMA, NMPA)

Market entry, expansion and growth strategies

Biotech pipeline evaluation and licensing                                

CRO and CDMO manufacturing

Strategic regulatory gap asessment

Regulatory roadmap

Regulatory roadmap implementation

Leadership and business coaching including mentoring for early stage founders

Assay and product development for research tools and diagnostics.

Technical and strategic consulting, including due diligence, independent review and design history file review.

Produc development process design and implementation (ISO 13485, ISO 9001) including risk management (ISO 14971).

Training, coaching and mentoring.

Early-stage drug development

Regulatory strategy

First-in-human and proof-of-concept studies

Programme management

Scientific & investment due diligence

Drug discovery & IND-enabling strategy

Translational science & clinical positioning

Partnerships, collaborations and communications

Clinical operations and portfolio management

Clinical trial and CRO/ site mangement

Service provider selection / management / oversight

People management and coaching / training

Marketing strategies and plans

Marketing messaging audits

Marketing messaging development

Marketing messaging implementation and copy

Regulatory strategy for FDA EMA PMDA agency meetings

Review of strategy planning for FDA EMA and Rest of the world Markets

Due diligence

Company structure and process analysis

Project management (comms, medcomms)

LinkedIn carousels

Posters

Presentations

Scientific 2D illustrations and graphics that make complex topics accessible

Expertise in anatomy, surgery, and cellular biology, including drug mechanisms of action

Clear, engaging visuals for websites, scientific publications, and educational materials

Strategic input on how to communicate science effectively through illustration

Press releases 

Media outreach 

MedComm (blogs, articles, newsletters, award applications, abstracts, web copy, social media posts)

Pitch deck optimization (investors meetings, conferences, board meetings)

Scientific data visualization from quantitative and qualitative data sources.

2D scientific illustrations, especially cellular biology and molecular mechanisms.

Graphic materials for screen and print: including annual reports, publications, educational materials, grant graphical abstract.

Audience-tailored communication support.

Medical and regulatory writing 

Scientific and technical writing

Quality assurance and quality control 

Regulatory intelligence

Craft clear, compelling biotech narratives that resonate with stakeholders

Translate complex science into clear, action-driving messaging

Guide communications through change, uncertainty, and growth with clarity and purpose

Facilitate insight-driven workshops that unlock alignment and drive momentum

Expert advisory and support for securing research funding.

Critical proposal review and end-to-end bid development for competitive UK and EU funding schemes.

Grant scouting and interview preparation to support successful applications.

Coaching, training, and bespoke workshops for researchers and teams.

Data stewardship and data management, specializing in R&D chemistry and small molecules data management.

Build efficient data strategies to unlock value for company and department, including change management.

Uncover and engage with all the teams involved to optimize data utilization and problem-solving in data management. 

Propose processes for data analysis and reporting to enhance decision-making

Cross company & funtional team leadership

Project roadmap development to support integrated drug development plans 

Risk & Opportunity mapping

Project & Change Management in drug development/business infrastructure projects via Agile & Waterfall 

Discovery, Preclinical and IND-enabling projects 

Cell Therapy Platform & Process Development 

Technical Expertise & Troubleshooting 

Overseeing project teams, ensuring smooth program execution and milestone achievement

Process development strategy, optimisation & troubleshooting

CMC strategy, IND/IMPD CMC support, raw material strategy & documentation

Tech transfer & GMP manufacturing oversight

Technical project leadership across ATMP programmes

LinkedIn ghostwriting

LinkedIn training and coaching

Content creation strategy and AI generated content

Phase appropriate Quality Assurance 

Hands on approach to developing Quality Systems

Inspection and Remediation Support

Detail oriented documentation writer