Offerings & Services
- Advisory Services
- Turnkey Project Solutions
- Quality Management Services
- Regulatory Affairs Services
- R&D projects/CDO Management Services
- BE Studies/CRO Management Services
- Technology/Site Transfer
- New Product Strategies
- Global Supply Chain Management
- New manufacturing/R&D Projects
- Business Development and M&A
- Fund Raising Support
- Intellectual Property
- Revenue Cycle Management
- IT & Non-IT staffing solutions
R&D projects, Contract Development Organization (CDO) Management Services
- Provide access to a large product pipeline which are under development: Titenare GXL has a network of large number of CDOs and access to their development pipelines for API, formulation, and device. Our goal is to ensure collaborative success for pipeline expansions for all partners.
- Provide market insights into the market potential for the products, launch dates, etc.
- Identification and selection of CDOs aligned with Client criteria and nature of studies
- Manage R&D projects and CDO’s of various types:
- Development only with technology transfer, or
- Full ANDA/eCTD/510K with BE/Clinical studies, and up to commercial supplies
- Technical and commercial due diligences of the selected CDO sites as per latest regulatory guidelines
- Project management including negotiations on scope of work, commercial and technical agreements
- Preparation of entire management and quality systems for the management of CDOs
- Audit of CDO sites as per target regulatory standards for USFDA, EUGMP, ROW, ISO
- Comprehensive monitoring of studies at multiple CDO sites
- Intermediate assessment of data and progress during product developments
- Assistance in review and finalization of study reports consistent with regulatory guidelines
- Drive significant cost savings; keep Client’s internal headcount down
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
- Strategy and branding
- 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
- Project Management
- 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
- Strategy and branding
- Pipeline Prioritization
- Competitor and customer perspectives
- Complete organization value maps.
- Implementation planning and support
- Market access: India, EU, US, RoW