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
Global Supply Chain Management
- Establish manufacturing strategies integrating current and future requirements
- Relationships Management
- Identify contract manufacturing partners
- Establish sound techno-commercial agreements
- Relationships Management
- Implement an integrated plan to manufacture various technologies, dosage forms and therapeutic categories.
- End-to-end supply chain management: from PO placement to delivery
- Fast launch planning
- Technical sourcing: Formulations, API, excipients, key intermediates, electronic items, molds, packing materials.
- Provide inputs on acquisitions, own set up, evaluation of various scenarios, etc.
- Risk assessment & mitigation options
- Bulk supplies with local packing strategies
- Establishment of warehouse/Inventory management system
- Establishment of end-to-end logistics support/management system
- End-to-end remediation project handling
CMO Management
- Manage identification, qualification, and quotes from multiple CMO’s. approved by USFDA/EUGMP/1348/UL, including API and device components
- Recommend to Client, help select a CMO, and provide CMO management oversight
- Negotiate supply agreement and quality agreement on behalf of the Client
- Qualification of CMO from screening, facility tours, system audit and review of following:
- Organization chart and structure
- List of all current Standard Operating Procedure (“SOP”) and policies
- Experience of regulatory audits, audit findings and responses by CM
- Training records with curriculum vitae and job responsibilities of investigators and other staff
- Create and facilitate estimation of Cost of Goods, commercial and technical agreements
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