AstaRE

Proven End to End platform for RE-formulating, RE-purposing and RE-positioning your products

Overview

Reformulation is a particularly attractive for off-patent drugs to keep them patented again through reformulation strategy, also to provide better safety, efficacy, bio availability and patient compliance.

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 for off-patent drugs to keep them patented again through reformulation strategy, also to provide better safety, efficacy, bio availability and patient compliance. Market access of repositioned or reformulated products in Europe and the United States is an interesting, 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

Product Development

Review of client product portfolio for identifying off-patent, data exclusivity, regulatory impositions, safety, efficacy, and quality information for products reformulation.
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Claims Review Support

Review reformulated product claims for new use or indications and establish the evidence from clinical, safety, efficacy, and toxicology to support the product new claims.
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Toxicology Assessment

Review of raw material/ingredients list for toxicology profile assessment of altered characteristics or added excipients of reformulation.

Clinical Assessment

Review of previous clinical trials data for efficacy and safety and leverage the trials data for reformulation product as appropriate to obtain regulatory approval.
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Medical Safety Assessment

Review of safety data of existing product from wide variety of sources such as spontaneous, literature to understand the current product safety profile and the safety implications on reformulated product.
AstaRE Service Offerings

Risk Management and Mitigation

All Clinical development activities to be conducted with appropriate risk management activities.

Regulatory Affairs Operations

Our regulatory affairs team is capable in understanding the different regulatory environment, ensuring compliance with regulation, and understanding opportunities based on the changing regulations. The team comprised of experts in the preparation, compilation, and delivery of regulatory submissions.

Pharmacovigilance and Post-Marketing Support

Collect, process and report the adverse events associated with reformulated products. Prepare periodic safety reports, risk management plans, clinical overview documents

Data Management

Provide data management services for managing, archiving technical and non-technical data of reformulated products.

Stability Support

Review of stability requirements for different temperature zones and assess the stability testing for based on regulatory requirements. Stability testing can also be conducted based on client requirements.

Statistical Analysis Support

Develop statistical relevance for trial protocol designing, sample size calculation, power calculation for clinical studies, statistical analysis
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Quality Assurance (Audits)

Our highly experienced Quality experts take pride in ensuring accuracy and efficiency throughout every aspect of complete product development lifecycle

Medical Affairs

Provide data management services for managing, archiving technical and non-technical data of reformulated products.

Platforms

We provide on demand cloud platforms for the below areas

  • Pharmacovigilance
  • CDMA
  • Regulatory Intelligence
  • SDEA Maintenance

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