Regulatory Affairs Case Study – Moving to OTC

Every day we work with some of the world’s biggest and most dynamic healthcare companies in the pharmaceutical and medical device sectors.  Our team has a well deserved reputation for service excellence and their ability to successfully manage the most complex issues on behalf of clients. That is why we have had a 100% success rate since 2002. In this regulatory affairs case study we look at an issue faced by a client and how we overcame that issue successfully.

The Problem

Recently we helped a client overcome a series of significant regulatory roadblocks to achieve a successful product launch. The client needed to reclassify their ‘First in Class’ product to ‘Over The Counter’ status. We advised them of the data requirements and guided them through the submission process. Following approval of the reclassification, we were faced with the next challenge – to change the invented name of the product to support the clients’ marketing strategy.

The company had previously tried to get their chosen name approved without our help, however on that occasion they had been unsuccessful.

The Solution

Our long standing positive relationship with the Competent Authority allowed us to arrange a meeting with the relevant assessors. We presented new perspectives and a strong rationale to overcome their objections. These were accepted by the Competent Authority and our client was granted their chosen product name, which was essential to their brand.

The client would not have been able to change the invented name or bring their reclassified product to market without our assistance.  In seeking our assistance, they overcame significant hurdles that they had not previously been able to overcome.

Talk To Us Today

We hope that the regulatory affairs case study above helped to shed some light on the work that we do for our clients.

Would you like us to help you to navigate the maze of regulatory issues? We have a team of regulatory affairs experts that have significant industry experience.  Call us in Ireland on 00353 52 61 76 706 or email us at

Alternately, if you would like to find out more about what we do and how we can help your company then complete your details below and we will get back to you as soon as possible.

Further Reading from Acorn Regulatory

Veterinary Clinical Trials: New EU Law & Global Approaches

Clinical studies are intended to advance animal health care by identifying the most effective therapies and practices for a given condition, or by advancing our basic understanding of the disease. Much like a clinical study in the human population, a veterinary clinical study involves research that gains information from animal patients.

Read more here.

Pharmacovigilance & Social Media in 2020

We have been tracking the role of social media in pharmacovigilance in social media since 2015.  We first wrote about it here.  5 years on, we are glad to say that the field has moved on substantially in terms of research into the practical applications of social media in Pharmacovigilance. Regulatory guidance for the industry, however, has yet to be updated.

Read the full article here.

Download Our Clinical Trials E-Book

Acorn Regulatory is a leading regulatory, pharmacovigilance, and clinical consultancy company headquartered in Ireland.  Our Clinical & Medical team works with the largest and the leading companies in life sciences to assist them in bringing their products to market.  The team, led by Dr. Danica Cvetkovic, has written extensively on the issue.  In the latest e-book from Acorn Regulatory, we look at the best and most popular articles from our Clinical & Medical team.

Download the e-book here.

A Practical Approach to Risk Management Plans

Writing a risk management plan (RMP) for the first time can be a daunting task. The RMP is a legally binding regulatory document submitted to health authorities and is a mandatory commitment for all Marketing Authorisation Holders in the European Union. The goal of the RMP is to improve the benefit-risk balance of a medicinal product by combining risk assessment and risk minimisation. The RMP is a complex document, but with the revised RMP module (March 2017), comes the revised EU template for RMPs (rev 2 format) and the RMP is now structured in a clear manner with less repetition and with attention to detail.

Read more here.


About the Author
Gemma Robinson, PhD
Managing Director
As Managing Director of Acorn Regulatory, Gemma Robinson is actively involved on client projects on a day to day basis and she leads a team of respected pharmaceutical, medical device, pharmacovigilance and clinical trial experts.  Gemma is also an active contributor to developing and promoting standards in the regulatory affairs profession and she has worked with a number of academic and not for profit organisations to encourage individuals to pursue a career in regulatory affairs and the broader STEM subjects. You can read more articles by Gemma by clicking the link below.
Other articles by Gemma Robinson PhD