Elixir Consulting

Without sufficient understanding on right Regulatory strategy for specific cases, many companies face delays in product registration that affect the costs. Therefore, right partner for strategic planning and monitoring Regulatory changes is the key for successful commercialization of a drug product. 

We provide comprehensive Regulatory services across the spectrum of product development, registration and commercialization. We deliver informed advice and core services and solutions for new product and market authorizations, regulatory Authority submissions, queries handling, post approvals, CMC and lifecycle management to help companies maximize their product’s commercial potential and market penetration with success.

Elixir consulting’s Regulatory expertise enables to understand and efficiently manage the demanding complexity of the diverse Regulatory requirements in order to successfully launch their products in new markets and maximize the value of the hardwork put into.

Elixir consulting offers following services :

  • Can provide a thorough Regulatory consultation and strategies to enter into GHC/ AFRICA and other markets.
  • Dossier development/writing/compilation / preparation and review and publishing in eCTD, NEES and ASEAN CTD formats.
  • Dossier conversion into eCTD with validation report
  • Vendor audit support
  • Product/herbal/health product In-Licensing
  • Dossier-due diligence /dossier gap analysis
  • Out-Licensing
  • Dossier life cycle management
  • Product classification in GHC (formerly GCC )
  • Artwork/package insert preparation
  • Labeling review and translation/arabic and other languages
  • Submission management country wise
  • Scientific advise and strategic regional advice
  • GMP inspection and mock audit
  • Tech/registration support in GCC countries (SFDA/NHRA/ MOPH, MOH UAE and Oman, Kuwait/Qatar/Africa region/Mauritius/Azerbaijan/UK and EU.
  • Pharmacovigilance support in EU/UK and GCC
  • Contract Manufacturing
  • Third Party Manufacturing
  • Co-Marketing
  • Product Management & promotion of branded generics