STARoDub Regulatory Affairs and Operations for Drugs and Medical Devices

STARoDub provides lifecycle management and quality assurance services to ensure market access registration dossiers for pharmaceutical, biotechnological and medical device products to enable compliance with industry regulations.

The company manages product lifecycles and liaises with regulatory agencies worldwide. It helps manufacturers meet key timelines for quick market entry, and reduces the risk of quality recalls and resolves issues. Its high-quality registration dossiers are submitted in electronic common technical document (eCTD) or non-eCTD electronic submission (NeeS) formats for a wide range of countries.

Regulatory procedures and regulatory agencies

STARoDub specialises in international regulatory procedures such as marketing authorisation applications (MAA), new drug applications (NDA), investigational medicinal product dossiers (IMPD), clinical trial authorisations (CTA), investigational new drug (IND) applications, Japan new drug applications (JNDA), biologics licence application (BLA) and drug master files (DMF).

It also supports manufacturers in obtaining ISO 13485 certifications and CE marks for medical devices in a timely and cost-effective manner.

The company prepares submissions for these processes at either a national level or at the European level, including EU decentralised procedures (DCP), mutually recognised products (MRP) or centralised procedures (CP).

STARoDub organises efficient interactions with regulatory agencies such as the European Medicines Agency (EMA), the European Directory for the Quality of Medicines and Healthcare (EDQM), the US Food and Drug Administration (FDA), the Japanese Pharmaceuticals and Medical Devices Agency (PMDA), and the China Food and Drug Administration (CFDA), as well as the Therapeutic Goods Administration (TGA), Health Canada, and notified bodies such as DEKRA.

Regulatory compliance and quality management

STARoDub develops comprehensive regulatory strategies to ensure products meet industry guidelines.

The firm also supports change management activities and executes regulatory tasks such as authoring of regulatory submissions, new applications, variations, renewals and medical device technical documentation.

STARoDub also sets up or maintains quality management systems based on requirements such as 21CFR 210/211 and 820; Eudralex; ISO 14971, 13485 and 9001; and EU Regulation 2017/745 MDR.

Decreasing time-to-market with strategic regulatory advice

STARoDub provides manufacturers with customised strategic regulatory advice and support.

Its teams are experienced in regulatory matters and different development, quality and manufacturing aspects of active pharmaceutical ingredients (API) and various finished dosage forms. The company can advise clients on the connections between different functional areas and stimulate implementation of time-to-market principles.

Worldwide business development

STARoDub utilises its knowledge of different languages, cultures and regulatory landscapes to support business growth and increase revenues in countries such as the US, Japan, Canada, Australia, New Zealand, China, Russia and Ukraine, as well as other areas of the Commonwealth of Independent States (CIS) and Europe.

About STARoDub

Founded in 2014, STARoDub offers cost-effective, flexible and strategic regulatory services to clients.

This EU-based small-medium enterprise (SME) utilises its experience and high-performance work approach to provide customised support for the development or marketing of medical products and devices.

It has executed projects for several clients, including MSD, Aspen, Kinapse, Patheon and Peercode.

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STARoDub B.V.

Industriestraat 14

5391 BR Nuland

Netherlands

+ 31 (0)73 20 350 10 www.starodub.nl www.ectd-starodub.com www.regulatory-consultancy-starodub.com

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STARoDub B.V.

Industriestraat 14

5391 BR Nuland

Netherlands

+ 31 (0)73 20 350 10 www.starodub.nl www.ectd-starodub.com www.regulatory-consultancy-starodub.com

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