Product Development and Regulatory Affairs Consulting

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Our in-house and integrated global product development and regulatory affairs consultancy, BioDesk, can intelligently guide your product from bench to market. BioDesk offers CMC/manufacturing, toxicology, clinical/medical and regulatory affairs expert consulting services and specialises in preparing products to swiftly enter the clinic or gain marketing approval. BioDesk works closely with clients to design and implement manufacturing and nonclinical plans, mindful of commercial timelines and budgets. BioDesk further adds value by ensuring that a global regulatory standard is inherent within client development programs.
NovotechNovotech is internationally recognized as the leading regional full-service contract research organization (CRO) in Asia-Pacific with a global solution. Established in 1996, Novotech has offices in 11 locations across the region, and site partnerships with major health institutions. Novotech provides clinical development services across all clinical trial phases and therapeutic areas including feasibility assessments, ethics committee and regulatory submissions, data management, statistical analysis, medical monitoring, safety services, central lab services, report write-up to ICH requirements, project and vendor management. Novotech has been instrumental in the success of over a thousand Phase I - IV clinical trials for biotechnology companies across a wide range of indications, with particular expertise in: infectious disease, oncology, metabolic and endocrinology, respiratory and allergy, neurology and psychiatry, inflammatory and autoimmune, cardiovascular, haematology malignancies, dermatology, musculoskeletal, pain management, ophthalmology and pain disorders. As the Asia-Pacific CRO with a global solution, Novotech has a unique capability through its in-house and integrated global product development and regulatory affairs Consultancy, BioDesk. BioDesk offers international regulatory, CMC and toxicology expert consulting across a wide range of therapeutic areas and indications. The BioDesk team have particular expertise in vaccines, stem cell therapies, cell and gene therapies, immunotherapies, ADCs, antibodies (incl. MAbs), GMOs, peptides and recombinant protein products. Finally, Novotech obtained the ISO 27001 certification which is the best-known standard in the ISO family providing requirements for an Information Security Management System. Together with the ISO 9001 Quality Management system, Novotech aims at the highest IT security and quality standards for patients and biotechnology companies. For RFP enquiries: Please fill out the form available at https://novotech-cro.com/talk-to-an-expert  We look forward to connecting with you during the World Vaccine Congress Washington Virtual Event!