Regulatory Affairs

Regulatory Affairs stands as a core pillar at the heart of PharmaAS. We can assist you in:

Regulatory Strategy:
  • Tailored strategies for all health products, adapted to specific country requirements.
  • Comprehensive dossier reviews to assess risks and opportunities.
  • Preparation of Scientific Advice meetings.
Regulatory Registration & Submission:
  • Expert creation and rigorous review of regulatory dossiers.
  • Readability User Testing.
  • EU translations.
  • Development and review of Core Company Data Sheets, SmPCs, and labeling to ensure total compliance.
Lifecycle & Maintenance
  • Handling Marketing Authorisation Application submissions, registration follow-ups, and agency queries.
  • Variations, renewals, transfers.
  • Detailed review of artwork to ensure all visuals and text meet regulatory standards.

Pharmaceutical development

A regulatory strategy is only as strong as the data supporting it. At PharmaAS, we don’t just file paperwork; we help you build your product from the ground up to ensure it is market-ready.

R&D & Innovation Support

  • Formulation & Process Development: Expert guidance across diverse dosage forms to ensure product stability and efficacy
  • Quality by Design (QbD): Implementation of QbD principles that integrate seamlessly into your manufacturing workflows

Strategic Pipeline Management

  • Asset Alignment: We help you align your R&D strategy with long-term corporate goals to maximize ROI.
  • Due Diligence & Advisory: Specialist technical assessments for investment firms and internal stakeholders.

Let’s talk about your pipeline. We are ready to help you turn innovative ideas into market-ready realities

Medical and Clinical

Led by a board certified Medical Director, PharmaAS provides the clinical depth required to bridge the gap between scientific research and regulatory approval.

Clinical Trial Support

  • Regulatory Submissions: Full support for clinical trial applications, scientific advice and other regulatory agency interactions.
  • Protocol Design: Focused on scientific integrity and medical safety oversight to ensure validity in line with ICH-GCP.

Medical Governance & Safety

  • Expert Statements: Creation of authoritative expert statements and clinical overviews for regulatory and Ethical Committee dossiers.
  • Document Review: Medical and clinical validation of Core Company Data Sheets (CCDS), SmPCs, and product labelling

Readability User Testing

When it comes to patient safety, clarity is everything. EU regulations require that every approved medicinal product and many medical devices include a package leaflet that is clear, accessible, and easily understood by the end user.

At PharmaAS, we bridge the resource gap for organizations by providing a bespoke, end-to-end testing service tailored to your project timelines.

Why Readability Matters

Our process confirms that patients and healthcare providers can:

  • Quickly Locate: Find key information within the leaflet immediately.
  • Clearly Understand: Interpret the text and visuals without confusion.
  • Correctly Act: Take the right action based on what they have read.

Our Specialised Approach

We offer efficient solutions designed to meet regulatory obligations with confidence:

Full Readability Studies:
Complete, end-to-end testing services that ensure full compliance with competent authorities.
Bridging Strategies:
If you have a generic product, a full study may not be required. We identify relevant Package Information Leaflets (PIL) and author the necessary Bridging Reports to save you time and cost.
Regulatory Alignment:
We ensure all information, both text and visuals, is prepared for approval by the relevant authorities.

Cost-Effective & Compliant. We ensure your patient information is not just a document, but a clear guide for safe use.

Knowledge Transfer & Education

PharmaAS offers the creation of bespoke training solutions for internal teams and external partners.

Custom Slide-Decks:

High-quality, expert-led training materials tailored to your specific therapeutic area or regulatory needs.

Internal & External Use:

Scalable education programs designed to align your organization with current industry standards