Regulatory Archives

Promotional Material

by Nick | Mar 5, 2021

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

by Nick | Mar 5, 2021

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

by Nick | Mar 5, 2021

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...

National Marketing Authorization Applications

by Nick | Mar 5, 2021

National Marketing Authorization Applications Decentralised, Mutual Recognition, National Procedures We have assisted in obtaining over 150 Marketing Authorisations via National procedure in Europe and CIS regions. We were/are involved in more than 25 Marketing...

Local Regulatory Affairs Support EAEU/CIS Region

by Nick | Mar 5, 2021

Regulatory Affairs Support in EAEU Region Our experts are qualified scientists with extensive experience in the pharmaceutical industry and clinical research. We provide registration procedure services in all Eurasian Economic Union countries, starting from medical...

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