Healthcare is a demanding task worldwide. To grow and innovate in this space, it is important to provide a secure place for both humans and animals.
EU Regulations have been imposed to set regulatory obligations and processes for manufactureres, marketing authorisation holders and distributors of medicinal products. RNI is here to support you within this everchanging regulatory environment..
RNI’s scientific experts and medical consultants can support pharmaceutical companies for human and veterinary products to submissions management for authorization and post-marketing procedures and obligations on risk – benefit profile of the medicinal products.
Medicinal products services includes:
Support on common technical dossier compilation, Modules 2-5 of e-CTD
Regulatory support in Mutual recognition (MRP) and decentralized (DCP) procedures
Analysis of the specific EU requirements
Support in post-authorization status of the medicinal product
Toxicological support for APIs, residuals impurities and extractables and leachables
Calculating the Permissible Daily Exposure (PDE) or the Health Based Exposure Limit (HBEL) in manufacturing sites for human and veterinary medicinal products, according to cleaning validation protocol requirements and Current Good Manufacturing Practice (CGMP) Guidelines
Pharmacovigilance Services:
Marketing authorization holders are required to monitor the risk-benefit profile of their medicinal products in post-authorization period of its lifecycle. The Reg. (EU) No 520/2012 has been imposed to all MAHs in order to detect, assess, understand and prevent any raised adverse effect or any other medicine-related problem.
RNI team can provide your company with the below services:
QPPV 24h support
Eudravigilance MAHs registration
XEVMPD registration
ICSRs management and submission
Medical Literature Monitoring
Periodic Safety Update Report (PSUR) authoring and submission
Training
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