Scius provides assistance at all stages of product development to clients in the pharmaceutical, biotechnology, and medical device fields. Scius also provides assistance in the writing and defense of CMC sections of regulatory applications.

Scius can help your company formulate development strategies for pharmaceutical and medical products, ranging from lead candidate selection to final regulatory submissions and post-market activities. Scius will always strive to optimise the efficiency and manageability of your development program.

Services provided include:

• Comprehensive product development strategies meeting international standards and regulatory requirements.
• Scientific advice.
• Management of Chemistry, Manufacturing and Controls (CMC) issues such as formulation changes, etc.
• Preparation and/or review of Quality (CMC) components of regulatory submissions worldwide in Common Technical Document (CTD/eCTD) format.
• Scientific writing and preparation of documentation of development work.