Inpharmatis Group
360-degree services for Eastern and Western markets

Due to the ongoing pandemic, firms across industries are forced to opt-in or accelerate digitalization of their systems and processes. However, there is additional pressure from the ever-changing regulatory environment in various geographies for the pharmaceutical industry. In the case of the CIS countries, there are many developments in pharmacovigilance and regulatory affairs, but there’s a massive difference in the stage of development of pharmaceutical systems in those 13 countries apart from the linguistic and economic issues. The Eurasian Economic Union (EAEU), an economic union between the Russian Federation, Belarus, Kazakhstan, Kyrgyzstan and Armenia, has resulted in many regulation upgrades, especially in pharmaceutical regulations, affecting both quality, pharmacovigilance and registrations of medicinal products and medical devices. To serve these potential markets, pharmaceutical organizations need assistance in understanding the complex regulatory affairs, pharmacovigilance, quality, linguistic and economic issues, and one consultancy that has created a unique coverage with their personnel to deliver relevant services is Inpharmatis Group headquartered in Riga, Latvia.

Situated geographically and strategically between Eastern and Western Europe, Inpharmatis Group has been helping organizations to obtain marketing authorization in EAEU to build a strategy for registrations and upgrading the existing registrations to Eurasian Economic Union policies. In addition, the company enables the development of compliant pharmacovigilance systems according to EAEU law. “We have been very successful in this “roadside assisting” organizations,” says Dr Polina Dombure, CEO, Inpharmatis Group. “We help organizations in Eurasian Union GMP compliance that is different from many other GMP procedures that have been followed earlier. What makes our consultancy unique? Digital orientation is what distinguishes us from other consulting companies. We employ advanced technologies that enable us to deliver faster, better, and more efficiently. Our core competencies (expertise) include pharmacovigilance, quality and regulatory services».

We have built a strong team with unique competencies, and people on board are our top priority. What makes us different is the presence in both Western and Eastern markets

The company works per ensures high degrees of transparency, a quality system and state of the art policies to ensure that their clients can realize their potential to make a breakthrough in these Eastern markets and be compliant as per the mandated requirement of the large and medium pharmaceutical firms.

Through their range of regulatory services and electronic solutions, Inpharmatis Group helps pharma companies to digitalize their internal regulatory processes and, prepare electronic dossier for successful submission in the EAEU and other regions, manage pharmacovigilance and quality systems. The company is oriented towards digitalization and focused on developing new ways to make the entire process more efficient. Inpharmatis Group leverages digital technology specific to their key competencies of pharmacovigilance, quality and regulatory. For example, Inpharmatis has developed a cloud-based solution, Prudenta, funded by the European Commission. Designed to provide electronic and instant access to published articles in local medical journals, Prudenta is integrated with artificial intelligence and validated workflow processes, and additional quality control checks that enables automation and centralization of the previously manual and expensive process mandatory for every pharmaceutical company.

From being a leading European GMP certification provider as a consultant in all CIS countries to helping a globally available COVID-vaccine undergo huge regulatory procedures in EMA and WHO, Inpharmatis has leveraged its expertise of Western and Eastern markets to deliver successful results to its clients.

The company now has eyes on the United States and other Western markets. “In the next five years, we’re seeing ourselves as a completely global company, with a focus on the areas of service that we are providing,” says Dr Polina Dombure. “Whilst we know that many health authorities in the Western world are already digitalized, we’re now very much concentrating on the rest of the world.” There’s much development in the pharmaceutical industry, and Dr Polina Dombure understands that many things can be done like medical information services and operating hotlines for the organizations.