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Dungarvan Enterprise Centre,
Old Friary Building,
Lower Main Street, Dungarvan,
Co. Waterford, X35 FX45,
Ireland.
European Regulatory Affairs Limited can provide the following services to Pharmaceutical Companies:
Your Trusted Partner in Pharmaceutical Regulatory Affairs
At ERA, we offer a comprehensive range of regulatory affairs services for both human and veterinary pharmaceuticals. Our team of experts is committed to ensuring your products meet regulatory requirements and achieve successful market access.
Explore some of our diverse portfolio of services – from A to Z:
1. Act as Marketing Authorisation Holder (MAH)
At ERA, we understand that being a Marketing Authorisation Holder (MAH) comes with significant responsibilities. Our team is well-equipped to assist your pharmaceutical company in fulfilling these obligations and ensuring compliance with regulatory requirements. Here’s how, and, what we can provide with the MAH service.
2. Active Substance Master File (ASMF) Services
We offer an all-encompassing ASMF service in which we can provide guidance, strategy, eCTD preparation, submission and updates to your ASMF.
3. Bioequivalence Review and Strategy
Ensuring bioequivalence is a critical aspect of pharmaceutical development, particularly when it comes to generic drugs and biosimilars. At ERA, we can assist you with bioequivalence review and strategy, helping you navigate the complexities of demonstrating equivalence to reference products.
You will have access to the latest legislation and guidance from our experts.
We can also assist with Biowaiver options as part of this assessment.
4. Centralised Procedure Management
Navigating the centralised procedure for regulatory approvals in the European Union can be a complex undertaking. At ERA, we have lots of experience with centralised procedure management, providing companies with expert guidance and support to help ensure successful approvals for their products.
How can we help in the area of Centralised Procedure Management
5. Certificate of Suitability (CEP) Services
We can help you with Certificate of Suitability (CEP) guidance and submissions both from a CEP holder and MAH perspective
6. Clinical and Non-Clinical Expertise
At ERA our team of clinical and non-clinical experts play a crucial role in enhancing the approval process and commercial success of your products. Here’s how our expertise can benefit your MAs and MAAs
7. Decentralized (DCP) and Mutual Recognition (MRP) Procedure Management
Securing regulatory approvals through Decentralized (DCP) and Mutual Recognition (MRP) procedures is crucial for pharmaceutical companies seeking market access across multiple European Union member states. At ERA, we specialize in managing these complex regulatory processes, offering expert guidance and support to streamline approvals.
8. Dossier Development and Audits
The preparation and maintenance of regulatory dossiers are pivotal in ensuring the compliance and approval of pharmaceutical products. At ERA, we specialize in preparing and maintaining dossiers, conducting dossier audits and offering expert support for dossier development.
Here’s how our services in this area can benefit your regulatory submissions.
9. eCTD compilation and Life Cycle Management
In today’s digital regulatory landscape, electronic Common Technical Document (eCTD) submissions have become essential for efficient and compliant regulatory filings. At ERA, we specialize in eCTD life cycle management, offering expert guidance and support to ensure the successful preparation, submission, and maintenance of electronic regulatory dossiers.
10. Environmental Risk Assessment Experts
ERA specializes in environmental risk assessments, helping you navigate the evolving regulatory landscape in relation to pharmaceuticals and the environment.
We provide guidance on conducting environmental impact assessments and developing environmentally friendly product profiles
11. GCP Inspection Readiness
Ensuring that your clinical trials comply with Good Clinical Practice (GCP) guidelines is essential to maintain the integrity of your research and the safety of trial participants. At ERA, we can assist you in GCP inspection readiness, offering expert support and preparation to help you navigate GCP inspections with confidence. Here’s how our services in this area can benefit your organisation.
Here’s how our services in this area of GCP can benefit your organisation
12. GDP guidance and Wholesale Distribution Authorizations (WDA) applications
Ensuring the safe and compliant distribution of pharmaceutical products is essential to safeguard public health. At ERA, we specialize in providing guidance on Good Distribution Practice (GDP) and assisting with Wholesale Distribution Authorization (WDA) applications.
13. National Procedure Management
Navigating the regulatory pathways for pharmaceutical approvals at the national level is a crucial step in bringing your products to market. At ERA, we specialize in national procedure management, offering expert guidance and support to ensure successful regulatory approvals in individual countries. Here’s how our services in this area can benefit your National MA applications and management.
Here’s how our services in this area can benefit your National MA applications and management.
14. Paediatric Investigation Plans (PIPs) and Paediatric Use Marketing Authorizations (PUMAs)
Fulfilling regulatory requirements related to paediatric populations is essential for pharmaceutical companies when developing any medicine. At ERA, we can assist you with your Paediatric Investigation Plans (PIPs), when mandatory and Paediatric Use Marketing Authorizations (PUMAs), offering expert guidance and support with the aim to reach successful approvals.
For full details on what ERA can help you with please click here
15. Product Information Services
SmPC, PIL, and Labelling/Mock-ups review, guidance, update, and submission
Accurate and compliant product information is vital to ensure the safe and effective use of pharmaceutical products. At ERA, we specialize in providing comprehensive services for Summary of Product Characteristics (SmPC), Patient Information Leaflets (PIL), and labelling/mock-ups.
16. Quality Overall Summaries
Quality Overall Summaries (QOS) play a pivotal role in regulatory submissions, providing a comprehensive view of the quality, safety, and efficacy of pharmaceutical products. At ERA, we specialize in preparing high-quality QOS documents that meet regulatory expectations and facilitate successful approvals.
Here’s how our services in this area can benefit your organization.
17. Regulatory Strategy and Guidance
Navigating the complex landscape of pharmaceutical regulations requires a well-defined regulatory strategy and expert guidance. At ERA, we specialize in providing comprehensive regulatory strategy and guidance services to help you achieve your product development and approval goals.
18. Toxicology Experts
We utilise a network of experts to assist you with any complex reports, analyses or guidance you may need to move forward with your registration project.
19. Training Services
Staying informed and well-prepared in the ever-evolving field of regulatory affairs is essential for pharmaceutical professionals and organizations seeking to navigate complex regulatory landscapes. At ERA, we offer specialized training services in regulatory affairs to equip your team with the knowledge and skills needed to excel in regulatory compliance and submissions.
Here’s how our training services can benefit your organization
20. User Testing and Self-Selection Studies
Understanding how users interact with pharmaceutical products and ensuring their ease of use is vital for product design, patient compliance, and overall safety. At ERA, we specialize in conducting User Testing and Self-Selection Studies to assess user preferences, behavior, and product usability.
21. Variations and Line Extension Procedures
Managing variations and line extensions for pharmaceutical products is essential for adapting to evolving market needs, ensuring regulatory compliance, and expanding product portfolios. At ERA, we specialize in providing expert guidance and support for variations and line extension procedures.
Here’s how our services in this area can benefit your organisation
Believe it or not we can do even more so if you need support and you do not see the service listed above please get in touch and we will see what we can do to help.
Our team is dedicated to tailoring solutions to your specific needs. Contact us today to discuss how our regulatory affairs services can benefit your pharmaceutical projects.