STARODUB

EXPERTS IN REGULATORY AFFAIRS

Strategic, Timely, Accurate, Regulatory Services To Every Client

Our Mission


Strategic

Timely

WE BRING Accurate

Regulatory

Services

Our Vision

 

Be the first choice

Be a lean and powerful team

Bring the best STAR's TO EVERY COMPANY

Our Values


Reliability / Trust

Team Work

Respect

Personal Excellence

Openness


About Us


The name STARoDub means the old oak in a Slavic language. The oak is considered a cosmic storehouse of wisdom embodied within its towering strength. The Celtic meaning of the oak tree is durability, purity, constancy, wisdom, strength, nobility, power and honor. Oaks are known to easily surpass 200 years of age, which makes the oak a powerful, life-affirming symbol.

STARoDub BV is a quality oriented organization that was founded in May 2014. The company started with one employee, the founder, and by the beginning of 2017 the company has grown to 18 employees. We strive to be a lean and powerful team, and to bring added value to our clients. We can provide either individual support or support as a team. For organizations developing and/or marketing human or veterinary medicinal products, medical devices or combination products, we offer support from high level scoping up to regulatory approvals in countries worldwide.

All employees are highly educated, highly qualified and have several years of experience in the (bio)pharmaceutical industry. We have in-depth knowledge of Small Molecules, Biotech/Biologics, Vaccines, Medical Devices, Combination Products, and Regulatory Operations. Please check “Our Services” for more details.

We have implemented a Quality Management System and strive to comply with GxP and ISO 9001/13485 continuously. Our organization knows short reporting lines enabling decisions to be made timely and efficiently. We have an external board of control, acting as the sparring partner to set the best course for our company.

With strong pharmaceutical quality knowledge, production expertise and capabilities for continuous improvement, the company is unique in its field. By using our knowledge and experience, as well as our flexible, improvement oriented, well organized and high performance work approach, we have successfully executed projects for several clients, e.g. MSD, Aspen, Kinapse, Patheon, Peercode and others.