Regulatory Affairs:

BenAstrum Life Sciences Institute specializes in developing and delivering inclusive regulatory e-training programs covering regulations, policies and guidance by the FDA, EMEA, Health Canada, ICH, WHO, USP, ISO etc, in various areas of operations including clinical trial applications, regulatory submissions, liaising with regulatory authorities, importation & exportation requests, recognition filings, due diligence audits and product classification.

BenAstrum’s expert instructors are key industry opinion leaders, each with vast regulatory knowledge obtained from various positions with regulatory agencies and managerial positions at Fortune 100 pharmaceutical companies. It is with this knowledge and experience that BenAstrum can complement your management of strategic internal and external communications, staff and reporting.

Sample Case Study

Client

A Regulatory Affairs executive, working with a leading Clinical Development company.

Location

Massachusetts, USA

Circumstances

The client was required to review and prepare a regulatory submission to the EMEA. Given that they were interested in exporting the product throughout the EU and the centralized process was deemed the best avenue.

Client Requirements

The client and team members were out-of-date with regulations pertaining to the EU , the competent authorities reporting structure and marketing authorization filings. The client also had a limited budget that could be devoted to consulting services, in addition expectations were high the the filling would be completed on schedule.

Solution

The client previously attended live web training courses with BenAstrum, and felt confident in selecting them to assist with their training requirements. BenAstrum’s experts identified the client’s specific training needs and ultimately tailored two existing BenAstrum training courses to meet the requirements, designing a half-day training titled “The Latest Requirements for European Filings and Submissions”. The course was delivered successfully, well within the client’s timelines and budget.In addition BenAstrum experts supported the client throughout the preparation of the submission, answering  questions and providing guidance via telephone and email.