Pharma Regulatory Services in Spain

Freyr provides Pharma Regulatory Services in Spain for drug/biological product companies to support MAA Submissions, change in Market Authorization Holder (MAH), selection of the RMS & CMS, QP, QPPV & Pharmacovigilance system master file (PSMF) as per AEMPS regulations.

Check out more details at – Pharma Regulatory Services in Spain

Comments

Post a Comment

Popular posts from this blog

Medical Device Regulation Report, Morocco, Registration

This report provides information on regulations imposed on medical device in Morocco for product registration, import permit, validity & renewal process, variations filing, legal representative and labeling. Summary Product definition and governing regulations; Information on medical device registration; Explains the process of registration through flowcharts; Precise information on health authority fees & timelines for registration; Additional information on the validity of registration, renewal process and variation filing Presents the regulations applicable on labeling; and Describes the information on import regulations, and the requirement of a legal representative. Check out more details at  Medical Device Regulation Report, Morocco, Registration
Read more

Best eCTD Software Tool for global eCTD Submissions

Freyr SUBMIT Pro is one of the best eCTD software tool which helps Life science companies in various regulatory submissions to global health Authorities. Smarter the electronic Common Technical Document (eCTD) publishing Software, smoother will be the eCTD submission process. It all depends on how effective an eCTD software is to create, validate, track, publish, view, and manage the entire documentation lifecycle inclusive of complete clinical/pre-clinical research data. In addition, the functionality to be considered is the eCTD Software’s adoptability to region-specific submission formats under strict eCTD guidelines and compliance timelines. It might be time consuming at times to manage or convert the existing data into different  region-specific eCTD templates / submission formats  like: Investigational New Drugs (INDs) New Drug Applications (NDAs) Abbreviated New Drug Applications (ANDAs) Marketing Authorization Applications (MAA) New Drug Submission (NDS) A...
Read more