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
Regulatory Affairs Services & Support on-Demand
- Competent team to undertake complete requirements for the Client’s geography
- Review of documents from R&D, Bioequivalence studies, API manufacturer and formulations manufacturing for NDA, sNDA, ANDA/eCTD readiness; 510K/CE/UL/ISO/IATF readiness, gap analyses and gap closure advisory.
- Compilation of NDA, sNDA, ANDA/eCTD, 510K/CE/UL with necessary coordination with various entities
- Submission of eCTD for EU, ANDA’s for USA, or any other geographic filings. Work with specific, compatible database tools
- Running Centralized procedures like Centralized/MRP/DCP (EU)
- Running of procedures for ANDA, and DCP/MRP, national phases
- Advisory on optimum filing strategies to reduce approval time and costs, filings & queries management, with customer as front end
- Guidance to R&D team during product development stages to ensure streamlined ANDA/eCTD/510K/CE/UL approvals
- Management of post approval changes / variations, renewals, and optimum strategies
- Review of active substance Drug Master File and actions closure
- Screening of in-licensing dossiers for registration success
- Coordination with Manufacturing, R&D, Quality, Artworks, Pharmacovigilance, and other functions for smooth integration of all ANDA/eCTD/510K/CE/UL documents to ensure regulatory compliances.
- Regulatory budget setting and costing based on Client product pipeline plans.
- Optimum regulatory planning for site transfer and technology transfer projects; establishing, gathering, and compiling documents for filing variations and new sourcing strategies
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