International Regulatory Services

We help new companies to improve importation/exportation of their products by helping them to register their products in some countries/regions as: MENA region, North America, Europe, USA, Africa, and Arab Gulf.
We also help manufacturers to get international licenses for their production lines like FDA, EMA, SFDA and other accreditations. International certificates like: ISO, FSSC, HALAL, WHO and other international certificates can be done by our international network of international consultants.
Our qualified experts can provide consulting advice from the early pre-IND/pre-CTA/pre-IDE stage of pharmaceutical development through to marketing applications.
Pharmaceutical Regulatory Affairs Services:
⦁ Dossier/submission preparation or review and filing
         ⦁ Pre-meeting packages, INDs/CTAs/IDEs and post-filing submissions, BLA/NDA/NDS/MAA/510(k)/PMA filings (US, Canada, EU)
         ⦁ Submission preparation to other worldwide agencies in European countries, MENA region, Africa, Arb gulf region and Asia
⦁ Development of regulatory strategy for the product’s life cycle
        ⦁ Consideration of international regulatory requirements
        ⦁ Meeting international filings
        ⦁ Revision of plans as guidelines change
⦁ Facilitate interaction with regulatory agencies, such as in meetings and conference calls, negotiations during development stages, submissions and submission approval process
        ⦁ Liaison with regulatory agencies on regulatory, Chemistry, Manufacturing and Controls (CMC), clinical and toxicology matters
        ⦁ Respond to regulatory agency questions
⦁ Regulatory classification of products across different jurisdictions
⦁ Provide expert regulatory CMC compliance advice throughout development
⦁ Work with Sponsors and regulatory authorities through the resolution of complex development issues
⦁ Act as US Representative for US submissions, as EU Agent in Europe, and as Canadian Representative for Canadian submissions
PHARMA ADVISOR’s regulatory operations experts offer complete electronic submission services including:
⦁ Electronic submission formatting, optimization, construction, assembly, and review 
⦁ Review of documents for compliance to electronic submission requirements for regulatory agencies 
⦁ Document conversion, bookmarking, hyperlinking, enhancement, optimization, and quality control 
⦁ Electronic Common Technical Document (eCTD) submission and lifecycle management services for various submission types
⦁ Conversion of paper dossiers (e.g., DMFs) to eCTD format
⦁ Medical device electronic submissions
We also manage marketing authorization projects:
⦁ National marketing authorization procedures
⦁ Mutual recognition procedures (MRP)
⦁ Decentralized procedures (DCP)
⦁ Centralized procedures (CP)

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