Regulatory Affairs (RA)
Straight Line experts can support you develop a strategy for your NDS and sNDS.
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Our expertise spans from innovator product in niche therapy areas such as rare diseases, oncology, gene therapy, all the way to generics and mainstream treatments.
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We are deep expertise in medical device approval submissions and combination products.
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Regulatory Consulting
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Regulatory strategy, license applications, post-marketing life cycle, reimbursement and Market Access consulting
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Agency Meetings management, Pre-ITA, Pre-Submission Appeal and Q meetings
2
Drug Approval Submission
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Application dossier compilation
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Product Classification, Request for Designation
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Clinical Trial Application Guidance and Submissions (ITA and IDE)
3
Risk Management Plan
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Risk Assessments: Evaluating new product risks in processes, products, and suppliers.
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Risk Mitigation: Implementing strategies to mitigate identified risks.
Get in Touch
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