. Integraleaf - Pharmaceutical Regulatory Services ^

Regulatory Services for Growth-Oriented Pharmaceutical Companies

Specialized QP and Regulatory Affairs Services for startups, SMEs, and newcomers to the pharmaceutical industry – efficient, secure, and scalable.

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Specifically designed for

For companies looking to grow – but lacking in-house resources or regulatory expertise.

Pharma-Startups Branchenfremde Gründer KMUs Mittelständische Unternehmen Wachsende Firmen

Our Core Competencies – Modular & Proven in Practice

🏆 Qualified Person Services

Our flagship service: Outsourcing your QP functions to our experienced experts

  • Qualified Person according to § 15 AMG
  • Responsible person for narcotics handling
  • Responsible person for wholesale according to AM-HandelsV
  • Head of Manufacturing under AMWHV and EU-GMP

⚖️ Regulatory & Compliance

GMP, GDP, GxP process development and professional auditing

  • Preparation for inspections and audits
  • Independent mock audits for EU-GMP readiness
  • Audit coordination in non-EU countries
  • Custom SOP development

📈 Business Development

Strategic support for market entry and growth

  • Go-to-market strategies
  • Product mix optimization
  • Supplier negotiations
  • Pricing strategy development

🛒 Purchasing & Sales

Experienced support in sourcing and market development

  • Strategic product sourcing
  • Supplier evaluation and selection
  • Sales channel development
  • Key account management

💰 Finanzberatung

Financial strategies focused on sustainable profitability

  • Investment evaluations
  • External audits
  • Value creation strategies
  • Bottom-line optimization

📢 Marketing & Events

Regulatory-compliant marketing for pharmaceutical products

  • Digital marketing strategies
  • Stakeholder communication
  • Trainings and events
  • Field sales training

Our Expertise in Numbers

40+ years

Qualified Person experience

40+ Events

Organized professional events

Across the EU

Regulatory expertise

All sectors

Pharma, Cannabis, Medical Devices

Ready for Professional Regulatory Services?

Whether setup, optimization or outsourcing – we handle your regulatory tasks efficiently, compliantly, and practically.

📧 Email Contact

info@integraleaf.de

Contact us for an initial consultation

📍 Our Location

Scheidter Strasse 27
66123 Saarbruecken

Personal consultation on-site available

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