Citius »» Altius »» Fortius

  • Synergene specializes in building collaborative partnerships that helps companies’ grow through access to unique / niche / innovative product portfolio and new international markets.
  • Synergene bridges cultural diversities and evolves synergistic alliances that complement local marketing strengths with global manufacturing expertise to improve partnership efficiencies in commercial or innovation terms with significantly faster market reach.
  • Team Synergene’s hands-on experience and ground insights and proven methodology involves market assessment, spot promising opportunities and mobilize the most apt resources to create faster pathways (sourcing, regulatory, distribution, marketing) in unpresented geographical terrains of India, Europe, Canada, Australia-New Zealand, Asia Pacific, Middle-East and LatAm regions.
  • A proven track record of obtaining and maintaining global compliance with multitude of GXP approvals for FDF and API manufacturing facilities and CROs from the world’s most stringent regulators like US FDA, EMEA, TGA, WHO-Geneva, MHRA, MCC, ANVISA among others.
  • Extensively worked on hands-on basis right from greenfield facility creation to product development to Tech Transfer to regulatory dossier compilation, running regulatory approval procedures till grant of MA, and full scale regular Commercial Manufacturing and Supply.
  • Highly experienced in a large range of dosage forms (from oral solids to small and large volume Injectables, lyophilised products, Pre-filled syringes, biologicals and vaccines, oncology, hormones, insulins, penicillins, cephalosporins) APIs, (highly potent, hormones, insulins, penicillins, cephalosporins), herbal and natural products, medicals devices, diagnostics and disposables.
  • Deeply engrained knowledge base with QbD orientation for ensuring comprehensive Global RA and GXP compliance.