Regulatory Services

As a result of highly regulated and competitive market worldwide, our network offers Regulatory Affairs services for medicinal products, GMP certification, product registrations. We work on national levels registration to fulfill our clients' expectations and demands for marketing authorization applications, preparation and updating of SmPC, package leaflets and labeling, variations and renewals, readability and user testing and many more.

We linking together a legacy of expertise to navigate the complex regulations and registration processes necessary to test new Drug Products and bring them to market. Experienced, on-site Regulatory Affairs teams ensure regulatory compliance by preparing and maintaining regulatory documentation such as:
>> CMC Quality Module Documentation in CTD Format Suitable for the Submission of IND, IMPD, NDA, and MAA Dossiers
>> EP-Certificates of Suitability (CEP)

Inthera PharmaMed in partnership with sister pharma group at Seatrack International Group anufacturing plants and the ability to develop APIs, Finished Dosage and Packaging in our network of facilities allows clients full access to integrated services, resulting in a simplified supply chain, reduced risk and cost associated with technology transfers, and ultimately faster production and delivery timelines Our facilities support customers with on-site regulatory affairs personnel for the documentation of CMC development projects in the CTD format for convenient inclusion in IND / IMPD/NDA/MAA filing dossiers.

Regulatory Consulting Services

1993 - 2017

Our Most Efficient Year

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Submissions (National, CP and DCP) We reformat and submit your pharmaceutical’s dossier to any member state in eCTD or Our regulatory managers have proven their experience in coordinating and completing CTD format.
> Dossier Compilation / Quality Overview Submissions at National Level recognized regulatory procedures. Dossier Compilation and Quality Overview Services • We can submit your dossier in your respective counntry • RMS and CMS services We offer: 3rd party representation. Pharmaceutical Regulatory Strategies Coordination and scheduling for DCPs, MRPs, CPs and National Procedures We can coordinate DCP slots with certain agencies ⚫ Clinical and non clinical overviews Quality overviews by a senior regulatory manager prior to submission to be prepare for MRP, DCP or CP Dossier reformatting to eCTD

Regulatory Services