Regulatory Affairs
RA department of Tekro is responsible for getting products successfully registered and approved by the competent authorities.
Based on our broad expertise and deep experience gained after 20 years in the strictly regulated area of Veterinary industry we can offer following services:
Development of registration strategy
Preparation of technical documentation (dossier, SPC, PI) for marketing authorisation in accordance with the Regulation (EU) 2019/6 and Commision Delegated Regulation (EU) 2021/805.
Variations of the terms of a marketing authorisation for VMP (requiring and not requiring assessment)
Electronic submission of applications (MA, VRA, VNRA, etc.)
Stability studies and reports (long-term, intermediate, accelerated, stability after the mixing into feed, after dissolving in water, etc.)
Environmental risk assessment (ERA)
Maximum residue limits (MRL) for VMP
Consulting services
More information about Regulatory Affairs?
Please, contact us...
