tailored solutions

FRACTIONAL CMC LEAD:
Acting as a temporary or part-time Head of CMC, providing strategic direction, technical leadership, and hands-on support to biotech start-ups throughout the drug-development process.
STRATEGIC LEADERSHIP: Providing strategic direction from preclinical development through commercialisation, aligning CMC, manufacturing, regulatory, and business plans to support efficient, value-driven progression.
STRATEGY DEVELOPMENT: Developing tailored CMC strategies that align product development, manufacturing, clinical supply, and regulatory pathways.
RISK IDENTIFICATION AND MITIGATION: Proactively identifying CMC risks early and implementing targeted mitigation strategies to keep development on track and support reliable regulatory and manufacturing outcomes.
NEW PRODUCT DEVELOPMENT AND LIFECYCLE MANAGEMENT: Providing end-to-end CMC support from initial product concept through development, commercialisation, lifecycle management, and post-market activities.

COMPREHENSIVE TECHNICAL AND OPERATIONAL DUE DILIGENCE: Conducting in-depth assessments of CMC, technical, manufacturing, and operational capabilities to inform investment, partnership, licensing, and acquisition decisions.
RISK IDENTIFICATION AND MITIGATION: Identifying technical, regulatory, manufacturing, and supply-chain risks early to enable proactive mitigation and support successful development and commercialization.
EVALUATION OF KEY FACTORS: Assessing development plans, quality systems, manufacturing processes, and CDMO capabilities to ensure alignment with industry standards, regulatory expectations, and project objectives.
INFORMED DECISION-MAKING: Providing clear, evidence-based technical and operational insights to help investors and biotech companies make informed decisions.

LEADERSHIP GAP COVERAGE: Providing interim leadership for technical and CMC functions, maintaining operational continuity and momentum during organisational transitions.
TEAM LEADERSHIP AND STRATEGY: Leading technical and CMC teams, advancing strategic initiatives, and ensuring effective leadership transitions and sustained operational performance.
ORGANIZATIONAL DESIGN AND CAPABILITY BUILDING: Supporting organisational design and restructuring while strengthening team capabilities, processes, and leadership to meet evolving business and technical needs.
TALENT REVIEW AND DEVELOPMENT: Conducting talent assessments and establishing targeted development plans to strengthen team capabilities, improve performance, and support long-term organisational success.
RECRUITMENT AND ONBOARDING SUPPORT: Supporting the recruitment of permanent technical and CMC talent and enabling a smooth, structured onboarding process for new hires.

MODALITIES: Providing expertise across the full supply-management lifecycle, including RFP development, supplier selection, contract negotiation, and supplier qualification.
SUPPLIER RELATIONSHIPS: Providing comprehensive support for managing CDMO relationships, optimizing supplier performance, strengthening strategic partnerships, and ensuring alignment with business and project objectives.
PROJECT MANAGEMENT: Leading technology-transfer projects, coordinating cross-functional teams, and ensuring smooth execution, adherence to timelines, and successful project delivery.
SUPPLY PLANNING & FORECASTING: Applying expertise in demand forecasting, supply planning, capacity management, and inventory control to build a reliable, efficient, and resilient supply chain.
PERFORMANCE TRACKING & KPIs: Establishing and monitoring supplier key performance indicators (KPIs) to drive consistent quality, on-time delivery, cost efficiency, and continuous improvement.

SCIENTIFIC ADVICE & AUTHORITY MEETINGS: Preparing and managing scientific advice requests and engaging with regulatory authorities to align product development strategies with regulatory expectations.
MODULE 3 DOCUMENTATION: Authoring and reviewing comprehensive Module 3 documentation for clinical and commercial products, ensuring alignment with regulatory requirements and supporting the consistent demonstration of product quality, safety, and efficacy.
RISK ASSESSMENTS & CONTROL STRATEGIES: Developing comprehensive risk assessments and control strategies for related substances, mutagenic and genotoxic impurities, elemental impurities, nitrosamines, and other regulatory concerns to safeguard product quality, patient safety, and compliance.

PROJECT SCOUTING: Participating in pitch events, partnering meetings, and industry forums to stay abreast of emerging trends and identify promising technologies, projects, and potential partners.
OPPORTUNITY MAPPING: Structuring, evaluating, and prioritizing promising technologies and assets within defined therapeutic or strategic areas to support focused investment, licensing, and partnership decisions.
ASSET IDENTIFICATION: Identifying and evaluating promising biotech and pharmaceutical projects, then helping shape them into well-positioned, investment-ready opportunities.
GAP ASSESSMENT: Identifying technical, regulatory, and development gaps in early-stage assets and defining practical, risk-based pathways to address them and strengthen their potential for investment or partnership.
INVESTOR ENGAGEMENT: Translating complex scientific and technical concepts into clear, compelling investment cases and connecting innovators with venture capital and strategic investors.

ORGANISATIONAL DESIGN: Assessing and redesigning R&D structures, governance, and ways of working to accelerate decision-making, strengthen accountability, and enhance innovation output.
CHANGE AND TRANSFORMATION SUPPORT: Guiding large-scale change initiatives across R&D and Technical Operations, including operating-model transformations, post-merger integrations, and capability-building programs.
OPEN INNOVATION AND PARTNERSHIPS: Developing strategies to systematically access external science and technologies through strategic alliances, licensing, co-development, and ecosystem partnerships.
STRATEGY DEVELOPMENT: Supporting R&D and product strategy development, portfolio prioritization, and end-to-end launch preparation for new therapies and platforms while aligning leadership around shared strategic goals.
TALENT MANAGEMENT: Mapping critical capabilities and resources while strengthening talent-management and performance systems to build organizational resilience and sustain transformation.