Regulatory Affairs Support

Helping you achieve positive regulatory outcomes

Regulatory Affairs Support

Helping you achieve positive regulatory outcomes

We can provide support from early phase drug development to maintenance of Marketing Authorizations

Our highly experienced consultants are specialists in all facets of pharmaceutical regulation, and can assist you with all of your regulatory needs across the entire product life cycle.

Our team helps clients achieve successful regulatory outcomes across continents

Our consultants boast domain knowledge within global regulatory processes, and are experienced in working with regulators within both the EMA and FDA.

We can provide support from early phase drug development to maintenance of Marketing Authorizations

Our highly experienced regulatory consultants are specialists in all facets of pharmaceutical regulation, and can assist you with all of your regulatory needs across the entire product life cycle.

Our team helps clients achieve successful regulatory outcomes across continents

Our consultants boast domain knowledge within global regulatory processes, and are experienced in working with regulators within both the EMA and FDA.


Full list of our Regulatory Affairs services:

  • Regulatory Strategy development
  • Regulatory Pathway analysis
  • Precedence within therapeutic area and technology
  • Competitor products overview
  • Regulatory guidance
  • Regulatory regulations and directives
  • Preparation of regulatory documentation
  • Variation management
  • Publishing strategy
  • Implementation/upgrades of publishing tools
  • Project management of initial submissions and life cycle management
  • Regulatory Publishing Intelligence advisory
  • Guidance on eSubmission readiness of documents

Pharma IT can provide a tailored solution that meets your needs

“We have a dedicated team of consultants ready to support you in the pursuit of positive regulatory outcomes. We can create a custom solution to assist you with a specific task, or provide a larger scale long-term solution.”

Sara Halskov

Principal Consultant


Full list of our Regulatory Affairs services:

  • Regulatory Strategy development
  • Regulatory Pathway analysis
  • Precedence within therapeutic area and technology
  • Competitor products overview
  • Regulatory guidance
  • Regulatory regulations and directives
  • Preparation of regulatory documentation
  • Variation management
  • Publishing strategy
  • Implementation/upgrades of publishing tools
  • Project management of initial submissions and life cycle management
  • Regulatory Publishing Intelligence advisory
  • Guidance on eSubmission readiness of documents

Pharma IT can provide a tailored solution that meets your needs

“We have a dedicated team of consultants ready to support you in the pursuit of positive regulatory outcomes. We can create a custom solution to assist you with a specific task, or provide a larger scale long-term solution.”

Sara Halskov
Principal Consultant

Do you need assistance with regulatory affairs?

Pharma IT can assist you with meeting regulatory requirements across the product life cycle

Do you need assistance with regulatory affairs?

Pharma IT can assist you with meeting regulatory requirements across the product life cycle