Starodub B.V.

Our experts guide clients through regulatory pathways for small molecules, biologics, ATMPs, vaccines, medical devices, IVDs, software, and drug–device combinations. We offer integrated support across regulatory, quality, manufacturing, and operational functions, including ISO 13485 QMS setup, strategic oversight, and tailored training. Our risk-based, solution-oriented approach accelerates time to market while ensuring compliance. We can also act as your EU Legal Representative for seamless European market entry.

Products & Services offered

Medicinal Products – Regulatory Support

• EU legal representation

• Quality/CMC, nonclinical, clinical support

• Orphan Drug, PRIME, Breakthrough designations

• Due diligence & gap assessments

• Scientific advice, protocol assistance, pre-IND meetings

• MAA, NDA/ANDA (505j & 505b2), BLA, and RoW submissions

• Clinical trial applications

Medical Devices – Full Support

• Technical file preparation, CE & QMS certification

• EU Authorized Representative & PRRC

• Product classification & applicable legislation (MDR/IVDR)

• Notified Body selection

• Risk management, biocompatibility, clinical evaluations, PMS/PMCF, vigilance

Quality, Manufacturing & Operations

• QMS implementation & improvement (e.g., documentation, change control, SOPs, training)

• Internal/external audits, audit preparation & remediation (FDA, EMA, etc.)

• Training & competency management

• Lean programs led by in-house Black Belts (incl. Yellow/Green/Black Belt training)

• Pharmaceutical production & quality leadership

• Qualification & validation: IQ/OQ/PQ, cleaning, process, method, facility, packaging, CSV