Service Sectors
Categories we Support
Pharmaceuticals, Therapeutic Products, Orphan Drugs
New Chemical Entities, New Drugs, Generic Drugs, Drug Master File
Biologics, Biosimilars, Vaccines, Advanced Drug Therapy, Cell Gene Therapy
Medical Devices and In-vitro Diagnostics
Cosmetics
Health Food & Supplements
Make the Right Choice with Us
How We Can Help You
With decades of experience in the team,
we support small, medium sized and multi-national Biotech companies with
Strategize, Expand and Execute with Us
Overview of our Consulting Roadmap
Business Need / Market Analyses
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Advisory
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Market survey
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Competition Landscape
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Feasibility
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Local partner survey
Regulatory Analyses / Regulatory Strategy
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Regulatory Intelligence
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Regulatory analyses
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Regulatory strategy
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Multi-country strategy
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Risk analyses and business advisory
Multi-country Regulatory Project Planning
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Submission plan
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Remediation plan
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Post-market planning
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Local partner planning
Regulatory Filing / Implementation
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Execution of plan
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Temporary marketing authorization holding
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Local legal representative
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Project management
Compliance / Business Maintenance
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Post-market reporting
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Compliance maintenance
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Business maintenance
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Variations
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Local legal representative
Benefits
Valuable Outcomes
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Cost-effective virtual solutions and regulatory outsourcing
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Single window project management backed by team of qualified consultants
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End-to-end Regulatory consultation, Marketing Authorization Application and License Holding of your products
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Expert support for multi-country region-specific regulatory complexities
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Local Responsible Persons or Pharmacists with Local language Interactions with Health Authorities (HAs)
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Structured approach to ensure smooth and satisfactory project delivery
We have Testimonials and Case Studies
Our Clients
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Pharmaceutical Manufacturers with own R&D molecules, Innovator or First to Market Generics
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Orphan Drug, right-to-license Pharma Product Owners
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Pharmaceutical Distributors with own or in-licensed products
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Cosmetics, Medical Devices Brand Product Owners, Manufacturers, Distributors
