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Local Regulatory Affairs Support

Home 9 Page Category: Regulatory Local Regulatory Affairs Support Insource our Local Regulatory experts. When and where you need them the most. Product lifecycle management is a challenge for Marketing Authorization Holders in a highly competitive market and a...

Regulatory Strategy and Dossier GAP Analysis

Regulatory Strategy And Dossier GAP Analysis Regulatory Strategy We set you up for regulatory success by managing the entire process from dossier writing to filing applications. Biomapas’ experienced regulatory affairs specialists hold an unmatched reputation...

Promotional Material

Promotional and Advertising Material Review Health Authorities regulate promotional materials and activities that companies engage in or sponsor and intend to influence the prescription and use of a drug product. All promotional content should comply with...

Medicinal Product Lifecycle Management

Medicinal Product Lifecycle Maintenance Medicinal product lifecycle management is defined as the process of managing the entire lifecycle of the product. This includes its clinical development, marketing authorization and post-authorization activities. As medicinal...

eCTD & NeeS Compilation

eCTD & NeeS Compilation Biomapas provides full support in Electronic Common Technical Document (eCTD) compilation and submission, as well as Non-eCTD electronic Submissions (NeeS). We use the eCTD Office software. Our team is fully prepared for new requirements...

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