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Business description

Acorn Regulatory provide regulatory affairs and compliance support to pharmaceutical and medical device companies globally.
We assist companies in all stages of growth, from start-ups to established multinationals. Our experience spans a broad range of therapeutic categories and thus allows us to fit in easily into existing team structures with minimum downtime required for training.
Acorn Regulatory can be the virtual office for SME’s and manage their entire regulatory or compliance requirements.

Products and services

Our pharmaceutical regulatory affairs services include:

• The preparation and submission of new marketing authorization applications
• Post licensing activities; variations, renewals, referrals, gap analysis and due diligence reviews
• Full in-house capability to create and publish applications electronically (NeeS/eCTD format)
• We also offer European Pharmacovigilance services and can act as your European QPPV and are registered users of Eudravigilance.

Our Medical Device Services include;
• Devising the appropriate regulatory strategy for your device
• Device classification
• CE Mark Certification for EU markets, US, Canada and emerging market product registrations, liaison with notified bodies and competent authorities
• Device vigilance, post market surveillance
• European Authorized Representative services
• Quality auditing: ISO 13485, internal auditing

Value proposition

Our team of regulatory experts consistently deliver high quality customised service to our clients, on-time and within budget. We strive to maintain this same high standard of professional support throughout every project (large and small).

Standards and certificates

  • ISO 9001: 2015 accredited Winners of Best SME at County Tipperary Business Awards 2017 Shortlisted for TOPRA Communications Award 207 Short listed for the 2012 Inspiration & Horizon Awards by The Organisation of Regulatory Affairs Professionals (TOPRA), UK.

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