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 have partner agreement with an Indian R&D organisation, and can therefor not only assist with advice and coordination of drug development, but also offer development of analytical methods, method validation and stability trials cf. ICH requirements, as well as formulation development.
We can also assist with connecting up with clinical CROs.
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.
Marketing Authorizations
Sirius offer assistance with:
Preparation of the Administrative Module (M1) and regional sections.
Preparation of Quality, Safety and Efficacy CTD Modules 2-5.
Regulatory review regarding the format and content of the dossier prepared by the company for submission, according to the chosen procedure.
Preparation and submission of dossier in e-CTD format. Preparation and submission of both veterinary and human dossiers.
Coordinate and running Centralised Procedure (CP), Decentralised Procedure (DCP), Mutual Recognition Procedure (MRP) and national procedures, and repeat use procedures.
Can offer to be local representative or temporary MAH.