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| We offer custom-tailored Regulatory Affairs Services including: |
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Marketing Authorisation Application (MAA) |
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NCE: normal process, fast track, orphan drug |
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eCTD |
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Generics |
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Biotechnology products |
Maintenance |
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Type I and Type II variations |
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Renewals |
Marketing Authorisation transfer |
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Product information |
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Local product information |
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Patient information |
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Abbreviated product information |
GSASA questionnaire Expert reports, overviews, summaries Reimbursement application Pharmacovigilance support Strategic consulting in regulatory matters Support in contacts with health authorities (Swissmedic, BAG) |
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Talent line |
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Ask for cost saving strategies in regulatory
affairs: + 41 44 932 30 32. |
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Contact us for support in regulatory affairs. |
