About AstaRE

Medicinal or non-medicinal products that have been developed and approved for one indication can be reformulated by changing or modifying their list of ingredients, physical or chemical properties of drug molecule for new indications or different formulations. Reformulation is a particularly attractive solution for off-patent drugs to re patent them through tailored commercial strategy. Additionally, this also provides better safety, efficacy, bio availability and patient compliance. Market access of repositioned or reformulated products in Europe and the United States is an interesting proposition – data exclusivity and patent rights through reformulation can provide significant commercial value to marketing authorization holders/pharma companies.

AstaRE offers specialized services for drug reformulations as per client requirements. The expert team at AstaRE is included with reformulation strategist, domain experts, data analysts, clinicians, project managers who can deliver range of reformulation services as mentioned below:

AstaRE: Customised formulations, within time and budget

• Global Regulatory Consulting for Claims Management, Labeling & ARP Submission
• Toxicology – Product Safety Assessment, Medical Review, Literature Search, Reporting
• Clinical Trial Management Support, Site Co-ordination & governance, Patiet Accrual, Contract Management
• Clinical Data Design & Programming, CRF Design, Statistics, Quality Control
• Project Managment accross sites, Identifying and tracking KPIs, Client Dashboards