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

Technical and business content creation (pitch decks, collateral, articles, webinars, infographics, brand videos, press releases)

Brand narrative and thought leadership creation to gain stakeholder and investor buy-in

Product go-to-market and content marketing strategies with multi-channel tactics

Market positioning-product fit audit, and messaging refinement

Global Clinical Trial Management: Lead and oversee Phase I-IV multinational clinical trials from

start up to close out.

Cross-Functional Leadership: Coordinate global teams, CROs, vendors, and investigators

Regulatory & Quality Oversight: Ensure compliance with ICH-GCP, applicable regulatory requirements, study protocols, and sponsor SOPs while supporting Quality by Design and risk-based trial management. 

Stakeholder & Financial Management: Manage study budgets, forecasts, vendor performance, and sponsor communications

Scientific and translational strategy and planning, including project/CRO/team management

Development and delivery of focussed research plans to turn exciting science into investable assets 

Assay development & screening cascade design & troubleshooting

Advice on implementation of human iPSC-derived cellular models 

Analytical strategy planning and implementation including analytical assay design, optimisation, and validation

Translational medicine support including data preparation for IND/CTA submission and clinical operations

CRO selection and management

GCP-compliant regulatory support, quality management system support, and INC/CTA submission

Operational CMC: Support in selection and management of CDMOs, process & analytical technical support, within applicable regulatory framework. 

Project management & mentoring: Day to day management of key deliverables of a project, mentoring of young project managers into the role, Internal and external stakeholder assignments. 

Gap analysis & Roadmap: Review of current state of the art, Gap identification & remediation plan drafting, ballpark cost estimates. 

Drug substance process development: In depth technical support for scalable process development of synthetic modalities

Scientific communication strategy, publication planning and data dissemination

Medical affairs, medical education, MSL training and compliance support

KOL and patient engagement, advisory boards, symposia and speaker training meetings

Scientific and medical writing, manuscripts, abstracts and congress materials

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

Scientific, portfolio and business strategy 

Early drug discovery from target ID to IND filing 

Project leadership and management 

Due diligence for in/out licensing of assets and platforms 

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

Market entry, expansion and growth strategies

Biotech pipeline evaluation and licensing                                

CRO and CDMO manufacturing

Investment rediness & funding strategy

Embedded leadership & scale execution

Venture builder and commercialisation

Operational turnaround, governance and restructuring 

Medical affairs strategy & MSL content development

Scientific publications & congress communication support

Market access materials, AMCP/formulary dossiers & value communication

Clinical evidence synthesis & medical communication strategy

Executive and C-Level Scientific Leadership (Fractional or Interim) 

Translational Strategy and Early Development Planning 

mRNA and Advanced Therapeutics Platform Advisory 

Pipeline, Platform, and Technical Due Diligence for Investors and Biotech Leadership

Study design and monitoring services for GLP Safety Studies

Drug development plan and Gap Analysis services

Project Toxicology to oversee early stage development to support first in human trials

Regulatory document authoring including CTD, pre-IND and IB documentation

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

Analytical and central lab Selection & Oversight (including RIF/RFP, BDM, audit)

Clinical Biomarker Strategy Expertise: flow cytometry, ELISA and multi-plex LBA, selection of secondary and exploratory endpoints

Supporting clinical trial protocol writing and review (SOA, biomarkers), laboratory manual specifications, translational SOPs

ELN/LIMS strategy for clinical sample virtual inventory and tracking analysis and reporting data flow 

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

Hiring roadmap design, organisational structure & compensation benchmarking from pre-seed to Series A

Founding team audit, skill gap analysis & investor readiness review for early-stage biotech ventures and academic spin-outs

Executive search & placement across all functions — scientific, medical, regulatory, commercial and technical — from junior to C-suite and board

Search & placement for co-founders, fractional consultants & key hires in early-stage biotech

Early-stage drug discovery
Platform positioning
Data management and analysis
Startups

Clinical project management

Clinical trial management

Clinical operations management

Study and Vendor oversight

Therapeutic target review & positioning 

Target biology derisking strategy 

Functional genomics & CRISPR 

CRO selection & management

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.

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

Preclinical development strategy and planning (nonclinical safety/toxicology)

Nonclinical gap assessments and due diligence evaluations

Nonclinical safety study planning, CRO selection and oversight

Regulatory interaction and document authoring

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.

Vendor selection support including CDMO operational assessment 

CMC project management (during preparation to First-In-Human trial, technical transfer, scale up or process validation)

GMP personalized trainings on demand

Interim team management

Clinical operations management

Clinical trial development, study and site management

Vendor/CRO selection, oversight and management

Fractional leadership and KOL advisory

Assay and product development for research tools and diagnostics.

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

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

Training, coaching and mentoring.

Clinical operations and portfolio management

Clinical trial and CRO/ site mangement

Service provider selection / management / oversight

People management and coaching / training

Phase appropriate Quality Assurance 

Hands on approach to developing Quality Systems

Inspection and Remediation Support

Detail oriented documentation writer 

Executive leadership: C-suite, Chief of Staff and operational leadership roles

Program and operational support. Day to day program management running diverse projects, up to setting up project management structures or governance, with strong stakeholder and alliance management across teams and external partners.

Commercial launch planning and management: Setting up launch processes and blueprints for biotech companies.

Start-up support. Strategic direction, fundraising support, regulatory strategy, and setting up Scientific Advisory Boards.

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

Support biotech and CGT organizations with site start-up, operational readiness, and tech transfer execution. 

Advise leadership teams on MSAT strategy, GMP manufacturing readiness, and commercialization planning. 

Provide hands-on expertise in deviation management, change control, and process optimization for complex advanced therapy platforms. 

Protein engineering solutions for complex biologics discovery & development 

Bioprocess solutions and protein engineering platform development

Project leadership and management (including CRO/CDMO selection) 

Business strategy

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

Medical and Scientific Writing (peer-reviewed manuscripts, review articles, congress abstracts, posters, and presentations/clinical slide decks)

Medical Comms (plain language summaries, educational articles, blog posts, and social media content)

Editing, proofreading, and fact-checking of scientific documents

Literature search and reference management

Medical and regulatory writing 

Scientific and technical writing

Quality assurance and quality control 

Regulatory intelligence

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.

Due Diligence

Candidate lead/format selection, Developablity and strategic planning

Early CMC support

Cell line development and Mammalian cell line recombinant expression platforms

Scouting & Diligence: Prioritize biotech assets with clear investment recommendations

Investor readiness: Build equity stories and support EU/US capital raises

Venture & Asset strategy: Define TPPs and value-driven development paths

Strategic partnerships: Identify partners and support high-impact discussions

Strategic regulatory gap asessment

Regulatory roadmap

Regulatory roadmap implementation

Leadership and business coaching including mentoring for early stage founders

Venture strategy and company building support for early-stage biotech ventures

Investor positioning, fundraising strategy, and partnering preparation

Preclinical development planning and asset strategy

Scientific, commercial, and strategic diligence for investors and venture builders

Clinical trial patient recruitment strategy, feasibility and retention planning

Trial recruitment rescue programmes for underperforming or delayed studies

Fractional Chief Patient Recruitment Officer support, including vendor oversight and recruitment leadership

AI discoverability and visibility audits for clinical trials, biotech companies, CROs and research sites

R&D Project Planning & Development Strategy

Chief Medical Leadership: Affairs & Clinical Development planning and execution

Document & Product Evaluations

Leadership Coaching & Governance

Narrative strategy development & visibility roadmap design for science startups

Founder content creation & thought leadership execution across platforms

Media training & spokesperson development for science-driven founders

Journalist engagement & earned media placement for biotech/health tech