News!
M.Sc. pharm. Elise Hellesø Rinvar is approved as QP by Malta Medicines Authority (Reg. no. 00000134). Please check the Malta Pharmacy Council database: Pharmacy Council Registration (gov.mt).
Experts within EU Regulatory Affairs, Pharmacovigilance, GDP & GMP
Welcome to Sirius Pharma Consulting Limited, a consulting company for the pharmaceutical industry, specializing in drug development, regulatory affairs, GMP, GDP, quality and pharmacovigilance.
We assist different companies with drug development, launch of products to the market and life cycle management. Our services cover all aspects of pre- and post-approval of medicines which include complete life cycle (marketing and distribution), facility compliance and approvals.
We offer services within following areas:
- Regulatory Affairs (drug development, obtaining and maintaining marketing authorisations for medicinal products/finished products, and Certificate of Suitability for APIs through EDQM)
- GMP/GDP (including audits and QP batch release for EU/EEA market)
- Assistance with end-to-end serialization and tamper evidence solutions (EU FMD requirements) through partnership with Kevision Group
- Pharmacovigilance
We are currently starting up in the second quarter of 2024 with partnership with an oral solid dosage form pharmaceutical equipment manufacturer.
If you have any requests, then contact elise@siriuspharmaconsulting.com.
Regulatory Affairs
Regulatory affairs professionals are an essential link between companies and health authorities. They ensure that each stage of product development is managed in an efficient and transparent way. They are responsible, as well, for regulatory compliance of pharmaceutical products during all stages of development through to approval and commercialization.
Drug Development
Sirius offer assistance with submission strategy. Regulatory gap analysis, due-diligence, product and indication prioritization, regulatory pathway optimization and acceleration strategy, labelling, marketing authorization applications, submission planning.
Sirius do also offer assistance with:
Coordination of development of generic drugs for EU including coordinate pharmaceutical development, planning, coordination and monitoring of bioequivalence studies and up-scaling from laboratory to pilot and production scale.
Being sponsor for bioequivalence studies.
