Expert guidance for pharmaceutical innovation
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Conduct market research to evaluate the demand for specific vaccines. Assess scientific literature to identify potential vaccine candidates. Analyze regulatory landscapes and funding opportunities.
Support in developing a Target Product Profile (TPP) and the necessary clinical steps to achieve it.
Provide advice on selection of appropriate technologies to enable achieving the target product profile. Assist with candidates’ design and technical troubleshooting during the development.
Consulting on preclinical research and toxicology studies. Assist in designing and conducting preclinical studies, including in vitro and in vivo testing. Provide expertise in immunological assays and characterization of vaccine candidates, including immunological analysis and biomarkers.
Provide recommendations on vaccine production techniques and scaling up manufacturing processes. Assist in establishing quality control measures and compliance with Good Manufacturing Practices.
Consulting on clinical development aspects, including critically reviewing clinical development plans, clinical study protocols, and study submission packages to national and supranational regulatory authorities. Guidance in selecting endpoints and patient populations for trials. Support on selection of appropriate tests including quality aspects and subsequent immunological analysis and data reporting. Consultancy on interaction with Contract Research Organization.
Advise on regulatory requirements for vaccine development in various jurisdictions (e.g., FDA, EMA). Assist in preparing submission documents for Investigational New Drug (IND) applications and marketing authorization.
Advice on safety evaluation of vaccines and pharmaceutical products, both before, during, and after clinical development.
Facilitate connections with academic institutions, pharmaceutical companies, and research organizations to foster collaboration. Support joint ventures and partnerships in vaccine innovation and development. Engage with policymakers and public health officials to promote vaccine uptake and address hesitancy. Provide expert testimony and insights on vaccine-related topics at conferences and public forums.
Support in writing and evaluating manuscripts for publication in a peer-reviewed scientific journal, related to (pre)clinical, toxicological, and epidemiological studies, including writing overviews or reviews.
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We are a consulting firm specializing in vaccine and immunotherapeutics early technical and clinical development development.
Our mission is to help our partners in driving pipeline innovation and enable growth.
We help accelerating the establishment of feasibility, technical development, proof of concept and early development of novel vaccines and immunotherapies by employing most advanced science and technologies while ensuring the highest standards of safety, efficacy, and regulatory compliance.
The founder, Dr. Vassilev, has a proven experience track record: 23 years in pharmaceutical industry development and 10 years in academic research.
We provide strategic guidance and scientific/technical expertise needed to navigate the complex landscape of biopharmaceutical development.
Please reach out for more information on our services and how we can help you achieve your goals in vaccine and immunotherapeutics development.