DDR
Efficient Medical Regulation Guidance

There have been staggering new developments in the world of medical innovations over the past decade. New medicines, medical devices, and drug delivery techniques are emerging each day within the healthcare industry. In genetics, for instance, the number of gene therapy products being developed has increased exponentially in the last two years, with breakthroughs in stem cell research and CRISPR. We also saw a rise in the creation of orphan drugs—medicines to treat singular, rare diseases—in the healthcare sphere. Another kind of medicine that gained a lot of traction in the healthcare industry is combination drugs, an amalgamation of medicinal products and medical devices.

However, with the advent of new forms of medicines comes tighter regulations and guidelines to ensure that they are administered to patients with the utmost care. Hence new rules often come out from time to time with emerging medical trends. For example, new regulations for medical devices and IVDs will come into effect from May 2021 and 2022, respectively. Many healthcare organizations either fail to adhere to the guidelines or cannot implement them on time as they come out. As a result, their product development process can face multiple bumps on the road like delays or denial of approvals for clinical studies, halting drug/device development. It is here that DDR—a European consultancy company—assists its clients in adhering to the regulations and guidelines laid out by the various health authorities.

Based in Barcelona, DDR was born to focus on medium and small pharma, biotech and core MedTech companies to provide them with appropriate scientific and regulatory expertise for the global development and registration of drugs and medical devices. Xavier Luria, CEO, DDR, states, “We try to say not only what the guidelines say you have to do, but also go beyond to find the most appropriate value to the companies in terms of their product development.”

We try to say not only what the guidelines say you have to do, but also go beyond to find the most appropriate value to the companies in terms of their product development

The company provides its services mainly to pharma, biotech and MedTech companies, government drug regulation projects, research and innovation wings of many enterprises, and helps in training and educating their clients about the guidelines.

DDR was founded by highly qualified European regulatory experts that include former members of National European regulatory agencies, former staff of the European Medicines Agency (EMA), and various FDA experts. The experts treat every project as standalone and work accordingly. DDR conducts a strategic analysis of every case to learn its intricacies and finds ways to interact with regulators in the most positive way to gain favorable outcomes. In summary, DDR treats every drug/device development as an independent project and builds a solid case that can be defended in front of relevant regulatory authorities.

Utilizing its proficiency in medical regulations and guidelines, the company has aided many clients in the timely development and registration of its products to enter European, UK and US markets. For instance, it helped a client carry out a re-examination of their medical product after the EMA had rejected it. After the re-examination, the product was found to be compliant and was soon approved. The client later launched the product in a timely fashion. In another example, DDR utilized strategic analysis to obtain mixed marketing authorization for a medicinal product instead of a hybrid one for a client. The case is worth mentioning as mixed marketing provides regulatory protections which are unavailable in hybrid authorization.

In the coming months, DDR is planning to actively participate in many medical projects, gain insights from them and help more clients with their regulatory expertise. For example, the enterprise is progressively focusing on neurodegenerative diseases like Parkinson's and ALS and is learning about therapeutic and medical devices approaches to tackling them. Additionally, DDR is keen on bringing Asian companies from Japan, South Korea, and China into the European regulatory framework and getting market authorization and CE Mark for their products in Europe. Also, together with another consulting company, the organization is sponsoring a platform known as EMA Solutions to aid clients in facing Oral Explanations with the EMA since they are critical parts of the product authorization process.