First of all A pharma Document or regulatory document is useful if certain things are done accurately because We deal with pharmaceuticals that means many lives depends upon us and we have to recheck everything as we are related to world’s health. Even a single mistake can take million lives.hence we have to be very careful every time
Following are some of the Pharma IP Capabilities
➢ Review of literature.
➢ Evaluation of patents and planning of non-infringing route (if required).
➢ Strategy planning and execution of formulation development work.
➢ Searching of formulation patents.
➢ Analyzing and interpretation of claims.
➢ Suggesting non-infringing formulation for Formulation & Development
➢ Drafting composition patent and prosecuting for different patent offices.
➢ Preparation of invalidation ground for different patents.
➢ Having patent searching, analyzing skill for ROW markets like Thailand,
Vietnam, Taiwan, North American Countries etc.
➢ Preliminary Patent Assessment Reports.
➢ Level clearance reports/ Freedom to operate reports for various markets.
➢ Drafting of Patent
➢ Prior Art Search / Patentability Search or Novelty Search using various
➢ Global Launch Calendar for constraining patents in issue.
➢ Searching patent equivalents in ROW countries, finding legal status and
giving IP comments.
➢ Giving possible entry dates for major markets & ROW countries.
➢ Patent Infringement Analysis for US, Europe, Australia, Canada & few ROW
➢ ANDA filing strategy for patents in Orange book.
➢ PPT’s for customer meetings based upon requirement & customer interest.
➢ Strategic opinion reports for the Invalidation or Non- infringement of
➢ Preliminary Reports for DCGI filing.
➢ Pre Grant opposition filings in India.
➢ Trade Mark Search.
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therefore you can check the website of government about all other acts and guidelines of the regulatory affairs of india Government site
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