We are all about putting our clients first

Starodub’s team includes experts who, in their previous roles, played a vital part in the successful merger between a U.S.-based company and a Chinese partner. Their leadership in aligning regulatory teams and guiding the integration process was instrumental in enabling the Chinese product portfolio to enter the European market. For Chinese medical device companies seeking entry into Europe,  looking for a strategic regulatory partner, Starodub offers the insight, experience, and commitment needed to succeed.

We have been working with Starodub for almost a decade, and throughout this time, their expertise and commitment have proven to be invaluable.

Starodub has consistently provided high-quality regulatory support tailored to our specific needs, helping us navigate complex requirements with confidence and clarity.

What stands out most in our collaboration is their professionalism, responsiveness, and genuine dedication to client success.

The team at Starodub is knowledgeable, flexible, and always willing to go the extra mile, which has made them a trusted partner for our operations in Europe and beyond.

We sincerely appreciate the partnership and look forward to continued success together.

Excellent support! Starodub consultant did a great job by picking up all projects very quickly and transferring all gained know-how-to knowledge. Highly recommend Starodub!

As a small startup, we received invaluable support from Starodub on our journey to secure Orphan Designation in the EU, which offers exclusivity and reduced fees – making it a key part of our regulatory strategy. From start to finish, the Starodub team acted as an extension of our own, contributing to our toxicology strategy and helping make our lead program a success.

The Starodub team, provides key expertise for ATMPs in Discovery and Early Development Stage. Their core team of experts is highly effective crafting the right messages and in engaging with authorities in a very effective format. They have been pivotal to ensure success and enable to deliver the necessary inflection points for the CAR-T programs of Cellula Therapeutics!

Very satisfied with the support and pro active approach in the various projects

Very knowledgeable and great work ethics. Very happy with your support!

The consultants are always available and ready to help, it is very lovely to work with you.

Great support, very happy to have you as our regulatory service provider. Can’t think of anything negative to say, only praise.

We have successfully accompanied and supported numerous joint projects with our clients as partners for many years now and we would like to thank you for your lasting flexibility, commitment and your extraordinary expertise. We greatly appreciate you as a reliable and technically competent partner and even if something seems impossible to realize, I know that you can provide a solution and the appropriate know-how.

We look forward to many more exciting projects with Starodub Consulting, which will take the Life Science and R&D world a step further.

For over a year now, we have been working satisfactorily with Starodub. Communication lines with the organization are short and smooth. However, it is primarily the individual consultants who contribute to the pleasant collaboration. They demonstrate good substantive knowledge and helpfulness, and flexibility is highly valued by them. Their commitment to our company and the RA team is high. In case of additional support, we can always briefly rely on another Starodub consultant, which we greatly appreciate.

We work since 2016 with Starodub. They supported us with our ISO 13485: 2016 quality management system, with the certification and with the maintenance. Starodub also provided professional support with internal and external audits. We congratulate Starodub with their 10th anniversary and look forward to continue our successful cooperation.

Starodub consultants worked with us for three years on IND/IMPD, MAA, BLA and ROW module 3 dossiers and responses to questions from global health authorities providing highly professional leadership to create aligned regulatory CMC dossier strategies and building robust dossiers for vaccines. They shared their extensive knowledge and experience in guidelines and legislation for biologics and vaccines and provided guidance and training to the CMC teams.

Working alongside this group of colleagues was an absolute pleasure; their professionalism, wealth of knowledge, amiability, and exceptional organizational skills made every project a seamless and enjoyable experience.

Starodub consultants are very knowledgeable and professional in regulatory affairs and dossier development. From the moment they enter the program, they create added value.