Tanim_Pharma_RLD_Sourcing_4_Page_Brochure
                     TANIM PHARMA
REFERENCE LISTED DRUG (RLD) SOURCING
Global comparator supply for bioequivalence studies, clinical programs and regulatory submissions
End-to-end comparator sourcing across US, EU and ROW markets
Tanim Pharma provides sourcing solutions for authentic reference products, with traceability, regulatory documentation
and controlled logistics. The service covers FDA-approved reference listed drugs, EMA-authorized reference medicinal
products and regional reference products, subject to product and market requirements.
What We Can Source
• Market-specific RLDs / comparator products for development and regulatory programs.
• Specified batches, expiry dates, quantities, strengths and dosage forms according to the project requirement.
• US / EU / ROW reference products with market-specific sourcing and documentation support.
• Temperature-sensitive products with controlled handling and monitoring where required.
Typical Applications
Bioequivalence Regulatory
Comparator supply for BE studies and generic Reference products and supporting documentation for
development. submissions.
Analytical Formulation
Products for analytical method development and Comparative products for formulation and development
validation. work.
Stability Clinical
Reference products for comparative stability programs. Active comparator supply for clinical requirements.
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RLD SOURCING — PROCESS & SUPPLY CHAIN
A structured workflow from requirement assessment through delivery and post-delivery support.
1. Request & Assessment Review product name, strength, dosage form, market, quantity, batch preference,
expiry requirement, destination and intended use.
2. Supplier Qualification Identify suitable sourcing routes and authorized distributors/manufacturers; assess
& Sourcing availability and applicable market requirements.
3. Documentation & Compile and verify available quality, regulatory, import/export and chain-of-custody
Compliance documentation.
4. Quality & Authenticity Check batch information, labeling, packaging integrity, storage conditions and
Verification supporting records before dispatch.
5. Shipping & Delivery Coordinate appropriate transport, including temperature-controlled shipping where
required, with shipment tracking and handling controls.
6. Post-Delivery Support Support documentation queries, storage guidance and compliance-related
follow-up after receipt.
Global Coverage
• United States: sourcing of FDA-approved reference listed drugs where applicable.
• European Union: access to EMA-authorized reference medicinal products and market-specific comparators.
• Rest of World: regional reference products with consideration of applicable regulatory and import requirements.
• Multi-country projects can be coordinated according to the product list, destination markets and documentation needs.
Indicative Lead-Time Planning
Tanim Pharma states that standard products may typically be sourced within 4–8 weeks, while specialized or regulated
products may require 8–12 weeks. Actual timing depends on product availability, regulatory requirements, destination and
sourcing route and should be confirmed during quotation.
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QUALITY, COMPLIANCE & DOCUMENTATION
Traceability and documented handling are central to the RLD sourcing workflow.
Area Support / Documentation
Authenticity Batch verification, packaging/label inspection and documentation review.
Chain of Custody Traceability records covering sourcing, handling and shipment.
Quality Records Certificate of Analysis (CoA) and Certificate of Conformity (CoC), where
available/required.
Regulatory Regulatory letters, import/export permits and other market-specific records, as
applicable.
Temperature Control Validated or appropriate cold-chain arrangements and temperature monitoring for
products requiring controlled conditions.
Storage & Handling Storage and handling instructions and shipping records, where applicable.
GDP & Quality Framework
Tanim Pharma reports that its products are handled according to international GMP and EU GDP requirements and that
Tanimswiss Pharma GmbH holds Swissmedic GDP license 512189-102657423. The company describes a quality
management approach that includes documented procedures, supplier qualification, audits, risk management and quality
review activities.
What to Include in an RLD Request
• Product / brand name and active ingredient
• Strength and dosage form
• Target reference market (US / EU / specific country)
• Required quantity and pack size
• Preferred batch number or batch characteristics, if applicable
• Minimum remaining shelf life / expiry-date requirement
• Delivery country and destination
• Intended use: BE study, clinical trial, analytical, regulatory submission, etc.
• Required documentation or special storage / transport conditions
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REQUEST AN RLD SOURCING QUOTATION
Share your product requirements and Tanim Pharma can assess sourcing options, documentation needs and delivery
considerations.
Recommended RFQ information
1. Product name / brand
2. Strength & dosage form
3. Reference market / country
4. Quantity / pack size
5. Batch & expiry requirements
6. Delivery destination
7. Required documentation
8. Target delivery date
Why Work With Tanim Pharma?
• End-to-end sourcing coordination from requirement review to delivery.
• Global sourcing capability across US, EU and ROW markets.
• Focus on authenticity, traceability and regulatory documentation.
• Support for temperature-sensitive and controlled-storage products where required.
• Swiss-based pharmaceutical operations with a stated GDP-licensed distribution framework.
VISIBLE CONTACT DETAILS
[email protected]
+41 77 943 8627
Tanimswiss Pharma GmbH
Sandgrubenstrasse 44, 4058 Basel, Switzerland
www.tanimpharma.com
www.tanimpharma.com/services/rld-sourcing/
Business hours listed by Tanim Pharma: Monday–Friday, 9:00 AM–5:00 PM CET. Product availability, lead times, pricing and documentation are
subject to confirmation for each individual request.
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