Business Support Management
We help our clients to understand national, domestic and global markets using market research and analytics in association with the industry's key opinion leaders. PharmaLeaf can also help set up (incubator service) and expand the operations of a pharmaceutical client.
We have the expertise and resources to hold licenses on behalf of the overseas clients / sponsors relating to regulatory activities including CT NOC, Marketing Authorization and Registration certificates. PharmaLeaf can assist the clients in areas relating to Legal and IPR, market research and analytics, pricing, healthcare insurance, marketing, promotion of label claims, logistics, supply chain and distribution to facilitate access to global markets.
Technical Project Management
PharmaLeaf project managers in the last decade have supported a number of projects with cross functional abilities including technical, scientific, medical & commercial projects in the clinical & CMC segments.
- Pre approval regulatory support during development
- Due diligence and audits (companies, submissions, sites)
- Post approval assessment of manufacturing changes and process / product deviations; stability updates
- Annual product reviews
Clinical / Non Clinical
- GCP / GLP Auditing
- Clinical Expert Report
- Review of Study design and protocol
- Compilation of clinical sections for dossiers