Comprehensive CMO Management Services
Technology/Site Transfer
- Identify and assess cost-effective alternatives to implement technology transfers
- Techno-commercial quantification of costs, benefits, timelines, reliability
- Provide complete infrastructure to execute TT projects
- Establish scope with manufacturing partners leading to technical and commercial agreements
- Manage TT projects and timelines, in unison with regulatory strategy, leading up to filing of variations and response to Health Authorities queries
- Establish alternate sources for API, excipients, capsules, packing materials, electronic items, molds etc. that lead to reduced cost of goods
- Comprehensive technical management of projects by integrating Technology Transfer, Quality Assurance, Regulatory Affairs, Formulations/Analytical knowledge base
- Managing smooth transition of Technology Transfer process from R&D center to CMO, and Site Transfer from current manufacturing site to new site
- Full range of services from setting up the SOPs, monitoring the project until success full commercial supplies
- Product Launch from scale up phase to commercial
- Manage technology transfer in multiple locations.
FLEXIBLE ENGAGEMENT MODELS
- Specific project based
- Rent-a-resource: Monthly retainer based
- Resource placement at the manufacturing sites
Business solutions and services
Access to right Products & Funding
BUSINESS DEVELOPMENT
- New Product Strategies – R&D, In licensing, out licensing
- Global product development
- Mergers & Acquisitions
- Advisory services
- Turnkey project solutions
- Fund raising support
Access to integrated Services
TECHNICAL SERVICES
- Facilities Design & Engineering
- Regulatory Affairs – Drug & Device
- Quality Management Systems
- Development Services – Product/Analytical
- API Development Monitoring Support
- Technology/Site Transfers
- Third Party Audit and Compliance
- ISO//CE Mark/UL certifications
- Global Supply Chain Management
- Intellectual Property
Access to right Markets
MARKETING & SALES
- Market Assessment
- Competitor Differentiation
- Pipeline Prioritization
- Competitor and customer perspectives
- Complete organization value maps.
- Implementation planning and support
- Market access: India, EU, US, RoW