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
BE Studies/CRO Management Services
- Identification and selection of CROs aligned with Client criteria and nature of studies
- TGXL has access to several CRO sites
- Drive significant cost savings
- Review of CRO/CDO SOPs, quality assurance and quality controls
- Approved by USFDA and EU Health Authorities, with successful NDA, sNDA, ANDA/CTD submissions
- Technical and commercial due diligences of the selected CRO/CDO sites
- March 2018 ICH Good Clinical Guidance driven unified standards for US, EU, and Japan
- Good Engineering Practices (ISO14971) for medical device
- Negotiations on scope of work, commercial and technical agreements
- Preparation of entire management and quality systems for the management of CROs
- Audit of CRO sites as per target regulatory standards for USFDA, EUGMP, ROW
- Comprehensive monitoring of studies at multiple CRO/CDO sites
- Risk assessment of recent computerized system validations
- Risk assessment of medical device product as per ISO14971
- Assistance in preparation of study guidelines and protocols creation. Medical device risk assessment
review - Intermediate assessment of data and progress during studies
- Assistance in review and finalization of study reports consistent with ANDA/CE Mark/IEC6060-1
guidelines
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