Regulatory Affairs

Regulatory Affairs

Pharmaceutical Regulation

Our team has considerable experience working with clients of all sizes to design bespoke strategies to deliver global registrations and compliance efficiently and cost effectively, while ensuring attention to detail and a high standard of work.

We can also use our comprehensive knowledge of the global regulatory environment to develop and implement creative and innovative strategies designed to maximise the long-term success of clients’ products.

Product Registration

We have a team of experienced consultants with wide-ranging industry experience in small and large Pharmaceutical companies. We can provide support with:

  • Dossier due diligence and gap analysis against EU requirements and industry best practice 
  • MAA submission preparation and management via National or EU procedures 
  • Lifecycle management such as variations, renewals, labelling updates, batch specific requests, MA transfers etc 
  • Regulatory Compliance support such as gap analysis and remediation planning as well as Health Authority communication in the event of a non-compliance 
  • Regulatory strategy to help clients choose the best submission strategy for their new registration or change 
  • Regulatory Project Management to assist with larger project work such acquisitions or site transfers 

We can work with your existing local partners to provide trusted support to EU and Global markets 

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Lifecyle Maintenance

Our team of consultants is experienced with post approval lifecyle maintenance and compliance such as: 

  • Lifecycle management such as variations, renewals, labelling updates, batch specific requests, MA transfers etc 
  • Regulatory Compliance support such as gap analysis and remediation planning as well as Health Authority communication in the event of a non-compliance 
  • Regulatory Strategy to assist with regulatory impact assessment of changes and advise on the best submission strategy for your company Regulatory Project Management to assist with larger project work such acquisitions or site transfers

We can work with your existing local partners to provide trusted support to EU and Global markets. 

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Publishing Services

Our expert publishing team can help you build your submission package in eCTD (or NeeS), QC check, validate and submit it to the national competent authorities (NCA).  We can also provide support in the following areas: 

  • eCTD lifecycle maintenance 
  • Dossier conversions 
  • eCTD Submission Strategy 
  • eCTD or NeeS Training  
  • Productively identify and address complex submission publishing issues. 
  • Assess problematic validation errors to resolve accordingly. 

Our flexible and competent team can turn your dossier to a submission-ready file with efficiency and quality. 

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Testimonial

The regulatory team assigned to us by Acorn Regulatory seamlessly became embedded into our wider team, they have been supportive and proactive in their approach with unwavering willingness to improve and enhance our portfolio

Regulatory Manager
Global Healthcare Company (2024)

I have worked with Acorn Regulatory on many OTC campaigns and at this stage have been more than impressed with the insight and overview that they brought to each of the campaigns we worked on. At times debate has been lively but always working towards the end point to enable work to get done”

Regulatory Affairs Manager
Top 10 Pharmaceutical company headquartered in the USA.