Sustchem S.A. offer service "Pharma Regulatory Services"
Basic Information
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Category
Subcategory & Sub-subcategory
Trade Type
Offer Service
Service Name
Pharma Regulatory Services
Details
Specifications
- Service Category: Pharma regulatory affairs services covering pre/post-authorization consultancy, marketing authorization applications (NAP/DCP/MRP), life-cycle management, and eCTD submissions.
- Regulatory Certification: Handles life-cycle management such as renewals and variations, and submission of regulatory-related documents directly to health authorities; beyond this, specific certifying bodies are not detailed in the listing.
- Capacity Scale: Batch/capacity scale is not disclosed in the listing; production is positioned for commercial contract-service volumes.
- Geographic Coverage: Geographic coverage is not detailed in the listing; the supplier serves regional and international pharmaceutical customers.
- Lead Time: Lead time is not specified in the listing; it is confirmed directly with the supplier at the time of order.
Other Information
Additional Description:
Regulatory support spanning pre- and post-authorization consultancy, marketing authorization applications (national, decentralized or mutual-recognition procedures), life-cycle management such as renewals and variations, submission of regulatory documents to health authorities, and eCTD submissions.
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