Investing in Excellence: Comprehensive Training on EU Registration Procedures and eCTD Submissions at PharmDedict
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31 Oct Investing in Excellence: Comprehensive Training on EU Registration Procedures and eCTD Submissions at PharmDedict

Posted at 19:47h in Regulatory Affairs by

At PharmDedict, we firmly believe in nurturing our team’s talents to achieve excellence. We understand that our people are critical to our success, and that’s why we’re committed to finding, engaging, and growing the best talent. With a strong focus on local expertise, we recognize that each market is unique, and local knowledge is essential for success, along with the knowledge of the respective processes at European level. An example of our commitment to the team, is our cooperation with Day Zero EHF, focusing on comprehensive and targeted trainings in the field of EU registration procedures (DCP, MRP) and electronic Common Technical Document (eCTD) submissions.

PharmDedict: A Commitment to Regulatory Excellence

PharmDedict has established itself as a leading local player in the pharmaceutical industry, specializing in regulatory consulting and services. Our dedication to excellence and commitment to providing top-notch regulatory solutions has earned us a respected reputation in the field.

Investing in Local Talent

We believe in the importance of developing local talent. The pharmaceutical industry is characterized by complex and ever-evolving regulations, and local expertise is the key to success. We are committed to finding and nurturing local talents who can navigate the unique requirements of each market.

Expertise at EU level, Local Support

To empower our local team, we cooperate in a pan-European network of experts. These experts offer guidance and support, sharing their knowledge and experience to address the nuances of different markets. This approach allows us to provide a tailored service that is both EU informed and locally sensitive.

The Benefits

The comprehensive training program equips the talented team at PharmDedict with advanced skills in EU registration procedures and eCTD submissions. This investment in our team results in several key benefits:

·         Advanced competence. Our team gains advanced knowledge in critical regulatory processes, enhancing their capabilities in managing regulatory procedures at EU level along with the local support.

·         Efficiency. With improved eCTD capabilities (expertise plus software), our team can manage and submit regulatory dossiers more efficiently.

·         Pan-European network. Our team benefits from the EuDRAcon network of experts, providing support and guidance in the ever-changing world of pharmaceutical regulations.

At PharmDedict, we believe in the transformative power of investing in our people. Our training program is a testament to our commitment to talent development. As regulatory landscapes continue to evolve, we are dedicated to providing our team with the knowledge and skills needed to excel in the field of regulatory affairs. Our investment in excellence ensures that we continue to deliver premium service to the pharmaceutical industry while nurturing the talents that drive our success.

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About Day Zero EHF

Day Zero is an Icelandic company formed in 2013, specializing in providing high-quality CMC, Pharmaceutical Regulatory Affairs, and Translation Services to Applicants and Marketing Authorization Holders in the EU/EEA. The company is a member of the EuDRAcon network.

Day Zero has a rich history of working with electronic Common Technical Document (eCTD) since 2005, offering extensive experience in converting dossiers to eCTD and creating electronic baselines for older products intended for EU and GCC countries.

As part of their commitment to the pharmaceutical community, Day Zero have developed and sponsor free eCTD software. Their eCTD indexer is released with an open-source license, and it can be easily downloaded from their website at http://ectd.is.