Regulatory writing

Trust your regulatory writing to writers trusted by regulators

Our specialist regulatory writers have decades of global experience and a proven track record of providing outstanding content strategy
and support

Clients (and regulators) from around the world have been impressed by their thoughts and words

We can help you:

  • Deliver documents throughout the product lifecycle that meet the evolving requirements from regulators and industry
  • Meet increasing demands for transparency by preparing regulatory documents that are disclosure-ready and consistent with other outputs (e.g. publications)
  • Succeed in a fast-paced business environment by providing you with writers who are quickly and continually developing new competencies to meet new expectations

Simultaneous submission specialists

Global regulatory teams are under increasing pressure to achieve simultaneous submissions in key markets, especially the US and Japan. Envision’s senior regulatory writers use innovative global work practices, as well as their local knowledge and language skills, to help clients prepare simultaneous submissions for the FDA and PMDA – quickly and cost-effectively

Why Envision

Experience you can trust

Our regulatory writers have decades of experience. No hand-holding or excessive oversight required

The global reach you need

Our writers have impressed regulators in the US, Japan, the EU, and other important markets. Local insights save you time and money

The flexibility you want

Our writers are quick to adapt to the changing environment and your end goal is always on our mind

Continuity of knowledge

Our employees are our owners, so our retention rate is the best in the industry