Medical and Regulatory Consulting

Novotech’s Medical and Regulatory Consulting team offers full range of pre-clinical, regulatory affairs support, medical and pharmacovigilance consulting services.

Novotech’s Medical Services team provides an interdisciplinary approach; coordinating medical writing, pharmacovigilance, medical monitoring and central lab services which are all fundamental to the continuity and operational success of every clinical trial.

Novotech’s Medical Services is aligned to client’s protocol-specific requirements and geared towards the delivery of targeted clinical parameters; while also providing both medical and safety oversight and regulatory support.

Novotech uses state-of-the-art pharmacovigilance platform, Oracle ARGUS, for safety monitoring and case processing.

Clinical development strategies

The right development strategy is critical to the future of your molecule and your company. With biotech companies investing in more complex and global programs, we see biotech sponsors increasingly considering locations outside of the US for their trials, such as Eastern Europe and Asia-Pacific. We see an increasing investment in upfront clinical development strategy, including the use of carefully designed protocols. These include multi-arm, multi-stage designs with adaptive randomization. In our view, an efficient approach to clinical trial design will have the greatest impact in containing the escalating cost of drug development.

Clinical Regulatory

Novotech provides first-class regulatory services to help expedite drug development within the complex and dynamic research environment.

The preparation of applications to HRECs/IRBs is a specialized regulatory task. Novotech a regulatory affairs consultancy, so has a strong tradition of providing regulatory affairs services to the pharmaceutical and biotechnology industries. Novotech’s senior regulatory specialists are dedicated to managing the ethics approval and regulatory process to ensure efficient and timely startup of all studies.

This deep experience in regulatory affairs covers the major institutions in the Asia Pacific.

BioDesk Core Services Include

• Developing clinical and product development plans.
• Getting client’s products GMP-compliant and ready for clinical or approval.
• Designing and co-ordinating client’s GLP-compliant toxicology studies in support of human studies and marketing approval.
• Writing all types of applications: pre-IND, IND, CTX, Orphan Drug Designations (ODDs) Paediatric Investigational Plans (PIPs), through to Marketing Authorisation Applications (MAAs).
• Vendor sourcing and management.
• Designing and writing protocols, investigator brochures and all modules in the Common Technical Dossier required for a Marketing Authorisation Application (MAA).