Metina PharmConsulting Private Limited offer service "ANDA Submissions and Approvals"
Basic Information
429
23
4
3.7(31)
Category
Subcategory & Sub-subcategory
Trade Type
Offer Service
Service Name
ANDA Submissions and Approvals
Service Provider(s)
Specifications
- Service Category: Regulatory consulting for ANDA submissions - regulatory advice, FDA correspondence, CTD dossier writing and eCTD conversion, submission support, and query response through to approval.
- Regulatory Certification: Direct experience managing FDA controlled correspondence and preparing CTD/eCTD-compliant dossiers.
- Geographic Coverage: Focused on the US FDA regulatory market.
- Lead Time: Not detailed in the listing; managed end-to-end from submission through approval.
Other Information
Additional Description:
Metina has managed numerous ANDA submissions and approvals, offering regulatory advice during product development, controlled FDA correspondence, CTD dossier writing and eCTD conversion, online submission support to the USFDA, and query response through to product approval.
Ratings
(0)
(0)
(0)
(0)
(0)
Comments
Filters:
Sort by:
No comments available.
Matched Products & Services
B2B matches based on trade type, category, specifications & price range
Similar Products & Services
Products & Services related to what you're viewing
People Also Viewed
Other products & services viewed by people who looked at this product
Leave your rating & comment