Targeted regulatory strategies defined for your product’s evolution
Early preparation and defining project outcomes and objectives upfront is critical to effective product development. Each product is unique and deserves a tailored approach informed by expert knowledge of the latest industry trends and pathways to market approval across different jurisdictions.
Accelagen’s strategic consultants perform a critical assessment of study information and scientific data to identify gaps and areas to address before we move forward. Through this critical analysis, we explore all avenues to ensure the scientific data will withstand the rigour of evaluation and gain positive approval.
From global registration programs to single-country post-marketing variations (and everything in between), each project is assigned a dedicated Project Lead who will track and report on progress, timelines and milestones to give you maximum transparency and peace of mind.
- Preparation of Drug Development Plans
- Regulatory expertise and guidance for drug development teams
- Facilitate interactions with Local and International Regulatory Agencies, including Type A, B or C meetings
- Coordination of Regulatory Agency meetings, including background package preparation
- Expert contribution of Chemistry Manufacturing Controls (CMC) development
How we work
Strategic consultation
Our team of leading experts remain an integral part of the project advisory and strategic consultation process from concept to commercialisation.
Identifying gaps and removing risk
Working in partnership with your team, we chart cost-effective, compliant pathways to regulatory successful
Connecting with regulatory authoritie
By working closely with the right regulatory bodies, we help you avoid unnecessary delays and penalties and expedite your product’s development process.
Regulatory strategy
case studies
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