our services
CMC LEADERSHIP.
- FRACTIONAL CMC LEADERSHIP: Acting as a temporary or fractional head of CMC for biotech startups, providing expert guidance throughout the development process.
- STRATEGIC CMC LEADERSHIP: Offering strategic direction from preclinical stages through commercialization, ensuring alignment with both manufacturing and regulatory plans.
- CMC STRATEGY DEVELOPMENT: Crafting tailored CMC strategies that integrate seamlessly with your product’s development and regulatory pathways.
- RISK IDENTIFICATION AND MITIGATION: Proactively identifying risks early in the process and developing targeted mitigation strategies to ensure smooth development.
- SUPPORT FOR NEW PRODUCT DEVELOPMENT AND LIFECYCLE MANAGEMENT: Providing ongoing support for new product development, from initial concept through lifecycle management and post-market activities.
CMC CONSULTING.
- MODALITIES: Expertise across a wide range of modalities, including small molecules, peptides, biologics, antibody-drug conjugates (ADCs), radiopharmaceuticals, and cell therapies.
- PHARMACEUTICAL FORMS: Comprehensive consulting for various drug formulations, including injectables (solutions, emulsions, lyophilized products), and solid dosage forms (tablets, capsules, oral films).
- CONTAINER CLOSURE SYSTEMS: Extensive experience with a range of container closure systems, such as glass vials, blow-fill-seal technology, pre-filled syringes, and infusion bags.
DUE DILIGENCE.
- COMPREHENSIVE CMC DUE DILIGENCE: In-depth CMC due diligence to support investments, partnerships, and acquisitions.
- RISK IDENTIFICATION: Identifying technical, regulatory, and supply chain risks to help mitigate potential challenges.
- EVALUATION OF KEY FACTORS: Assessing development plans, quality systems, and CDMO capabilities to ensure alignment with industry standards and project goals.
- SUPPORTING INFORMED DECISIONS: Assisting investors and biotech companies in making informed decisions.
INTERIM MANAGEMENT.
- LEADERSHIP GAP COVERAGE: Providing temporary leadership for technical functions to ensure operational continuity during transitions.
- TEAM LEADERSHIP AND STRATEGY: Leading teams, driving strategic initiatives, and ensuring smooth leadership transitions.
- ORGANIZATIONAL DESIGN AND CAPABILITY BUILDING: Supporting organizational restructuring and enhancing team capabilities to meet evolving business needs.
- TALENT REVIEW AND DEVOLPMENT: Conducting talent assessments and creating development plans to strengthen the team’s skills and performance.
- RECRUITMENT AND ONBOARDING SUPPORT: Assisting with recruitment for permanent roles and ensuring a seamless onboarding process for new hires.
SUPPLY MANAGEMENT.
- MODALITIES: Expertise across a wide range of supply management functions, including RFPs, supplier selection, contract development, and supplier qualification.
- SUPPLIER RELATIONSHIPS: Comprehensive consulting for managing relationships with Contract Development and Manufacturing Organizations (CDMOs), ensuring optimal performance and strategic partnerships.
- PROJECT MANAGEMENT: Extensive experience in managing tech transfers, ensuring smooth execution, timelines.
- SUPPLY PLANNING & FORECASTING: Expertise in demand forecasting, supply planning, capacity management, and inventory control to ensure a reliable and efficient supply chain.
- PERFORMANCE TRACKING & KPIs: Proven track record of establishing and tracking key performance indicators (KPIs) for suppliers, ensuring consistent quality, on-time delivery, and cost efficiency.
REGULATORY CMC.
- SCIENTIFIC ADVICE & AUTHORITY MEETINGS: Expertise in preparing and managing scientific advice requests, as well as engaging in meetings with regulatory authorities to align on product development strategies.
- MODULE 3 DOCUMENTATION: Extensive experience in authoring and reviewing Module 3 documents for both clinical trials and commercial products, ensuring compliance with regulatory requirements for quality, safety, and efficacy.
- RESPONDING TO REGULATORY QUESTIONS: Proven capability in managing and responding to questions raised during regulatory reviews, providing clear, accurate, and compliant information to support approval processes.
- RISK ASSESSMENTS & CONTROL STRATEGIES: Expertise in developing comprehensive risk assessments and control strategies, including for related substances, mutagenic and genotoxic impurities, elemental impurities, nitrosamines, and other regulatory concerns to ensure product safety and compliance.
With a unique blend of hands-on experience, technical expertise, and a flexible, solution-driven approach, we meet each client’s challenges with precision and efficiency, ensuring success at every stage of drug development.