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Vertical File Cabinet

Medical Affairs & Regulatory Compliance

Empowering medical affairs teams to drive strategic impact and success

What it is

We help life sciences teams communicate science clearly and meet regulatory and compliance expectations—without creating unnecessary complexity. We combine strong medical writing with practical governance, efficient review workflows, and tools that make day-to-day compliance easier.

Who it's for

  • Medical Affairs and Medical Information teams

  • Regulatory Affairs / AdPromo and compliance-focused functions

  • Commercial and brand teams needing compliant scientific and patient-facing content

  • Patient engagement teams setting up governance and documentation practices

  • Cross-functional teams that need clear SOPs, standards, and review workflows

  • Small to mid-size biotech/pharma teams that need expert support without adding headcount

Services
Writing in Notebook

Medical Writing

  • Clear, consistent scientific and medical content for internal and external audiences

  • Editing and restructuring support for existing content

Team Collaboration Meeting

Patient Centricity Governance

  • Governance framework that support compliant, meaningful patient engagement

  • Simple, usable processes for review, documentation, and cross-functional alignment

Virtual Reality Experience

Immersive Communications (VR/AR)

  • Support for compliant scientific communications using Virtual Reality (VR) and Augmented Reality (AR)

  • Useful for education, training, and engagement experiences

Doctor Reviewing Documents

Medical Information Support

  • Creation and improvement of medical information content (responses, FAQs, standard letters)

  • Process support to improve consistency, quality, and speed

Business Card Stack

HCP & Stakeholder FMV Tools (Rate Cards)

  • Fair market Value (FMV)/rate cards for HCPs and other stakeholders

  • Support for transparent, consistent, and defensible compensation approaches

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SharePoint
Development

  • SharePoint sites and workflows for reviews, document control, libraries, dashboards, and team hubs

  • Practical builds that help teams find what they need fast and keep the right records

Smiling Professional Woman

Procedural Document Development

  • Development or refresh of Policies, Standards, SOPs, and Guidelines 

  • Practical documents that teams can actually follow (with clear roles, steps, and templates)

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AI for Review
(Human-in-the-Loop)

  • Using AI to organize feedback, compare versions, spot inconsistencies, and reduce rework

  • Guardrails to maintain appropriate oversight and traceability

Hands Shaking Globe

Multi-Region Regulatory Coverage

  • Support designed to work across key regions, including UK, EU, US, Canada, and Singapore (and more as needed)

  • We help you align content and processes to regional expectations while keeping a consistent global approach

Team Meeting Discussion

Let's make compliance simpler - and easier for everyone

Book a discovery call and we'll recommend a right-sized approach for your content, governance, and regional needs

+1-202-802-7770

contactus@optipharmmedical.co.uk

2028 by OptiPharm Medical, LLC. All Rights Reserved.

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