Regulatory & Medical Writing

The responsibility of a regulatory medical writer is to provide the highest quality scientific documents that can help organization to sail through the agency review process with minimal or no queries. Regulatory medical writing has become more complex with the introduction of new requirements to secure drug approval. Pharmaceutical companies that submit products containing a new active substance for regulatory approval to the European Medicines Agency are required to produce a Risk Management Plan.  Regulatory submissions to the US FDA require Risk Evaluation and Mitigation Strategy (REMS) documentation to support the approval of some classes of drugs (i.e., analgesic products that may be abused). For Pharmaceutical companies speed-to-market is paramount to gain an advantage over their competitors. A regulatory medical writer has to understand the data to interpret it correctly as well as have the ability to summarize the statistical findings. These complex and highly scientific documents need to convey a story in an understandable and transparent manner to enhance the drug submission process. DDReg has expert medical writers well trained in medicine and clinical pharmacy to author the medical documentation that is required by worldwide regulatory agencies.

Our services in this area include

  • Clinical Overviews & Summaries
  • Non- Clinical Overviews & Summaries
  • Development of Product labels, SPC, CCDS, PIL, PIs
  • Investigator’s Brochures
  • Product Monographs

Other Services

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