Tanimswiss Pharma RLD Sourcing Overview
                     TANIMSWISS PHARMA Web: www.tanimpharma.com Email: [email protected]
Global RLD Sourcing & Comparator Solutions
Swiss Precision in Reference Listed Drug Sourcing, Bioequivalence Supply, & Quality Compliance
Executive Summary
Tanimswiss Pharma is a specialized pharmaceutical service provider delivering end-to-end solutions across the
healthcare value chain. Operating at the intersection of regulatory rigor and supply chain reliability, Tanimswiss
Pharma provides compliant Reference Listed Drug (RLD) sourcing, clinical trial comparator supply, and formulation
technology transfer services to generic pharmaceutical developers worldwide.
Core Sourcing Commitment
We guarantee 100% full supply-chain traceability, GDP-compliant temperature-controlled handling, direct procurement from
authorized channels across US, EU, and ROW markets, and full regulatory audit packets to accelerate generic submission
approvals.
Strategic Importance of RLD Sourcing
In generic drug development, obtaining the authentic Reference Listed Drug (RLD) or Reference Medicinal Product
(RMP) is critical for characterization, formulation matching, bioequivalence (BE) testing, and comparative dissolution
profiling. Sourcing from verifiable and compliant channels prevents bio-inequivalence risks, submission rejections,
and study timeline delays.
Key Sourcing Pillars
Global Regulatory Coverage GDP & Cold-Chain Integrity
Direct access to FDA-approved RLDs, EMA-authorized End-to-end continuous temperature logging (2°C–8°C,
RMPs, and regional reference products across Japan, -20°C, ambient) with validated thermal packaging from
Brazil, UK, and APAC. origin to site.
Single & Batch Multiplicity Full Documentation Support
Capability to secure single specific manufacturing batches Complete regulatory packets supplied with every
or multi-batch commercial lots for extensive analytical shipment, including Certificate of Analysis (CoA), CoC, and
profiling. export/import permits.
Tanimswiss Pharma GmbH | Reference Listed Drug (RLD) Sourcing Division Page 1 of 5
TANIMSWISS PHARMA Web: www.tanimpharma.com Email: [email protected]
Global Sourcing & Regional Capabilities
Tanimswiss Pharma leverages an extensive network of GDP-licensed distribution hubs, qualified pharma wholesalers,
and direct manufacturer connections across major pharmaceutical territories to supply verified innovator samples.
Region Regulatory Agency Product Category Key Sourcing Features
United RLD / NDA / BLA Exact US package sourcing, single/multiple lot
US FDA (Orange Book)
States Standards consistency, fast US export clearance.
European EMA / National RMP / Centrally & Country-specific pack sourcing (DE, FR, ES, IT), EU GDP
Union Agencies Nationally Approved release, multi-language leaflets.
United Post-Brexit compliant sourcing pathways, UK qualified
MHRA UK Approved Comparators
Kingdom person (QP) releases.
Japan & Hard-to-source Asian reference products with localized
PMDA / NMPA / TGA Regional Reference Drugs
APAC documentation translations.
Rest of ANVISA, Health Customized regional procurement for local regulatory
Innovator Market Samples
World Canada, LATAM bioequivalence filings.
Comprehensive Supply Chain Safeguards
Counterfeit and degraded reference drugs severely jeopardize clinical trial validity and bioequivalence results.
Tanimswiss Pharma enforces strict Good Distribution Practice (GDP) protocols across every stage of the
procurement cycle.
1. Chain of Custody 2. Anti-Counterfeiting 3. Thermal Assurance
Unbroken pedigree documentation Physical inspection, batch Validated thermal containers fitted
tracking product movement directly verification, and serial number with real-time calibrated data
from licensed manufacturers or validation against official loggers ensuring continuous
authorized primary distributors. manufacturer databases prior to temperature monitoring.
dispatch.
Supported Dosage Forms
Solid Oral Dosage: Immediate-release, extended-release, delayed-release tablets, hard/soft gelatin capsules, orally
disintegrating tablets (ODT).
Injectables & Biologics: Lyophilized powders, pre-filled syringes, liquid vials, monoclonal antibodies (mAbs) requiring
strict cold chain (-20°C / 2°C–8°C).
Inhalation & Nasal: Dry powder inhalers (DPI), metered-dose inhalers (MDI), nasal sprays.
Topical & Transdermal: Creams, ointments, gels, transdermal therapeutic patches.
Specialty Formulations: Liposomal formulations, nano-suspensions, and narrow therapeutic index drugs.
Tanimswiss Pharma GmbH | Sourcing & Regulatory Compliance Page 2 of 5
TANIMSWISS PHARMA Web: www.tanimpharma.com Email: [email protected]
Integrated Technology Transfer Services
Beyond RLD sourcing, Tanimswiss Pharma offers complete Technology Transfer governance for EUCTD and CTD-
ready pharmaceutical dossiers, bridging product development with commercial-scale manufacturing.
EUCTD / CTD Transfer Governance
We manage risk-based analytical method transfers, process validation alignment, and regulatory variation filings to ensure
smooth commercial scale-up without quality loss.
4-Phase Tech Transfer Methodology
Phase 1: Discovery & Gap Analysis Phase 2: Risk Planning & Protocol
Comprehensive evaluation of donor facility technology, Formulation of detailed Tech Transfer Master Plans
CQAs (Critical Quality Attributes), CPPs (Critical Process (TTMP), ICH Q9 quality risk assessments, and analytical
Parameters), and receiving site capability matching. method transfer protocols.
Phase 3: Execution & Validation Phase 4: Regulatory Submission
Hands-on support during pilot/exhibit batch trial runs, Compilation of Module 3 (Quality) CTD/EUCTD
process validation (PV), scale-up monitoring, and stability documentation, site variation filings, and post-transfer
testing setup. regulatory approval support.
Analytical & Formulation Capabilities
Core Service Area Technical Scope Regulatory Compliance
Analytical Method HPLC/UPLC, GC, Dissolution, Particle Size, Assay & Impurity
ICH Q2(R1) / USP 
Transfer method co-validation.
Process Design, Process Qualification (PPQ), Continued Process EMA / FDA Process Validation
Process Validation
Verification (CPV). Guidelines
Accelerated, long-term, and intermediate stability studies under
Stability Testing ICH Q1A(R2) Guidelines
ICH climate zones.
Legacy dossier remediation to modern CTD / eCTD standards for
Dossier Upgrades EU Annex 1 / FDA Guidance
regulatory approvals.
Tanimswiss Pharma GmbH | Technology Transfer & Quality Systems Page 3 of 5
TANIMSWISS PHARMA Web: www.tanimpharma.com Email: [email protected]
Strategic Partnerships & Co-Development
Tanimswiss Pharma collaborates with pharmaceutical companies, CMOs, and R&D organizations to build risk-sharing
partnerships, co-development models, and strategic portfolio expansion frameworks.
Therapeutic Areas of Focus
We actively support RLD sourcing, dossier licensing, and co-development across diverse therapeutic fields:
ONC  Oncology & Hematology CVS  Cardiovascular Diseases
Targeted oral therapies, cytostatic injectables, high- Antihypertensives, statins, antiarrhythmics, and
containment complex oncology molecules. combination drug formulations.
CNS  Central Nervous System MET  Metabolic & Endocrinology
Neurological treatments, psychiatric disorders, controlled Diabetes management, peptide formulations, metabolic
substances, modified-release drugs. syndrome therapies.
INF  Infectious Diseases DERM  Dermatology & Topicals
Novel antibiotics, antivirals, anti-fungal agents, specialty Steroidal and non-steroidal ointments, gels, creams,
anti-infective formulations. transdermal delivery systems.
Value Creation Model
Our collaborative operational structure delivers clear strategic advantages to generic drug developers:
Accelerated Time-to-Market: Parallel execution of RLD procurement, method development, and regulatory dossier
preparation reduces development lead times by up to 30%.
Mitigated Regulatory Risk: Pre-audited supply chains and complete regulatory documentation packages eliminate
submission deficiency letters related to comparator authenticity.
Flexible Commercial Structures: Out-licensing, co-development, and contract development models customized to client
commercial goals.
Global Access Network: Seamless bridging between Western regulatory markets (FDA/EMA) and emerging
manufacturing hubs.
Tanimswiss Pharma GmbH | Strategic Partnerships & Portfolio Management Page 4 of 5
TANIMSWISS PHARMA Web: www.tanimpharma.com Email: [email protected]
Quality Assurance & Compliance Standard
Quality is embedded in every procedure at Tanimswiss Pharma. Our operational framework complies fully with EU
Good Distribution Practice (GDP) standards and international regulatory requirements.
Quality Assurance Guarantees
Every RLD batch supplied is accompanied by complete batch documentation, verified certificates of analysis, temperature log
reports, and importer/exporter authorizations to guarantee seamless regulatory acceptance.
Standard RLD Procurement Workflow
Step Action Item Deliverables / Output
Client provides product name, target market, required batch size, Feasibility assessment & price quote
1. Inquiry
expiry date requirements. within 24–48 hours.
2. Sourcing from licensed distributors / direct innovator source, Batch reservation, shelf-life verification,
Verification batch identification. CoA review.
Customs clearance, GDP temperature-controlled shipment via Airway bill, real-time temperature log data,
3. Logistics
qualified couriers. tracking.
Final QA release, delivery to laboratory or clinical research Complete regulatory packet, delivery note,
4. Delivery
organization (CRO). invoice.
Get in Touch with Our Expert Team
Whether you are planning a bioequivalence study, searching for hard-to-source innovator samples, or preparing a
complex technology transfer project, Tanimswiss Pharma is your trusted partner.
Tanimswiss Pharma GmbH
Website: www.tanimpharma.com
Email Contact: [email protected]
RLD Sourcing Service URL: www.tanimpharma.com/services/rld-sourcing/
Contact us today to request a comparator quote or discuss your generic drug development pipeline.
Tanimswiss Pharma GmbH | Global Contact & Service Overview Page 5 of 5