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New Registration
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New Registration
- Scoping and business case development and registrability assessments -assessment of data requirements
- Designing a weaning registration strategy that includes, costs of pursuing registration, schedules, and risk adjusted regulatory path.
- Risk assessments
- Developing protocols and coordinating local data generation (chemistry, toxicity, and efficacy testing necessary
- Documentation (In consultation with clients prepare and submit applications with all necessary forms and documents)
- Responding to regulators comments and questions
- Commercial label preparation
- Preparing distributor and repack registrations
