Frequently Asked Questions

Delios Lifesciences is a WHO-GMP certified pharmaceutical export company specializing in comprehensive export solutions for pharmaceutical manufacturers worldwide. We facilitate the export of pharmaceutical products to over 50 countries across Africa, Asia-Pacific, Latin America, Middle East, and Caribbean regions.

Our services include regulatory dossier preparation (CTD/ACTD), product registration, export documentation, customs clearance, GDP-compliant logistics, and temperature-controlled distribution.

We export pharmaceutical products to 50+ countries across multiple regions:

• Africa: Nigeria, Kenya, South Africa, Ghana, Tanzania, Ethiopia, Uganda
• Asia-Pacific: Philippines, Vietnam, Myanmar, Cambodia, Bangladesh, Sri Lanka
• Latin America: Brazil, Mexico, Colombia, Peru, Chile, Argentina, Ecuador
• Middle East: UAE, Saudi Arabia, Qatar, Kuwait, Jordan, Oman, Bahrain
• Central Asia: Kazakhstan, Uzbekistan, Turkmenistan, Kyrgyzstan, Tajikistan

We handle a comprehensive range of pharmaceutical dosage forms:

• Tablets: 500+ SKUs including immediate release, sustained release, enteric-coated
• Capsules: Hard and soft gelatin capsules, 300+ formulations
• Syrups & Suspensions: Pediatric and adult liquid formulations with taste-masking
• Injections: Sterile injectables, lyophilized vials, ampoules, pre-filled syringes
• Ointments & Creams: Topical formulations, dermatological products
• Oncology Products: Cytotoxic formulations with HPAPI containment

Minimum order quantities vary by product category and destination market. Generally:

• Tablets/Capsules: 50,000 - 100,000 units per SKU
• Syrups: 5,000 - 10,000 bottles
• Injections: 10,000 - 25,000 vials/ampoules
• Ointments/Creams: 5,000 - 10,000 tubes

We can accommodate smaller quantities for new market entry or product trials. Contact us to discuss your specific requirements.

Yes, all our partner manufacturing facilities are WHO-GMP and PIC/S certified. We work exclusively with manufacturers that meet the highest international pharmaceutical quality standards.

Every shipment is accompanied by WHO-GMP certificates, Certificate of Pharmaceutical Product (COPP), and comprehensive quality documentation.

Yes, we provide comprehensive regulatory support including:

• CTD/ACTD Dossier Preparation: Complete Module 1-5 compilation per ICH guidelines
• Product Registration: ANDA, NDA, MAA submissions to regulatory authorities
• Regulatory Strategy: Pathway selection and submission timeline planning
• DMF Preparation: Drug Master File documentation
• Query Management: Responding to regulatory deficiencies and queries

Our regulatory team has achieved 600+ successful approvals across FDA, EMA, MHRA, and 50+ regulatory authorities.

CTD (Common Technical Document) is the internationally recognized format for regulatory submissions adopted by ICH (International Council for Harmonisation). It consists of 5 modules:

• Module 1: Regional administrative information
• Module 2: Summaries (Quality, Nonclinical, Clinical)
• Module 3: Quality (CMC - Chemistry, Manufacturing, Controls)
• Module 4: Nonclinical study reports
• Module 5: Clinical study reports

ACTD (ASEAN Common Technical Dossier) is the format used by ASEAN countries (Philippines, Vietnam, Thailand, Malaysia, Singapore, etc.).

We prepare complete CTD/ACTD dossiers with all required documentation for regulatory submissions.

Regulatory approval timelines vary significantly by country and product type:

• FDA (USA): 10-30 months for ANDA (generics), 6-12 months for 505(b)(2)
• EMA (EU): 12-18 months for MAA
• MHRA (UK): 10-14 months
• Asia-Pacific: 6-18 months depending on country
• Latin America: 8-24 months
• Africa/Middle East: 6-12 months

These are approximate timelines. Fast-track pathways may be available for certain products. Contact our regulatory team for country-specific guidance.

A Certificate of Pharmaceutical Product (COPP) is an official document issued by the regulatory authority of the exporting country (as per WHO format) certifying that:

• The pharmaceutical product is approved for marketing in the country of origin
• The manufacturing facility is GMP-compliant
• The product meets quality and safety standards

COPP is required by most countries as part of the product registration process. We provide authentic COPP certificates for all our products.

We provide comprehensive documentation with every shipment:

• Certificate of Analysis (CoA): Batch-wise quality test results
• WHO-GMP Certificate: Manufacturer's GMP certification
• Certificate of Pharmaceutical Product (COPP): WHO format certificate
• Free Sale Certificate: Authorization for product sale
• Commercial Invoice: Detailed product and pricing information
• Packing List: Complete shipment contents breakdown
• Bill of Lading / Airway Bill: Shipping documentation
• MSDS: Material Safety Data Sheet
• Certificate of Origin: Product origin verification
• Stability Data: ICH-compliant stability study reports (if required)

A Certificate of Analysis (CoA) is a batch-specific document issued by the manufacturer's quality control laboratory certifying that the product has been tested and meets all specified quality parameters.

CoA typically includes test results for:

• Assay (active ingredient content)
• Dissolution (for oral solid dosage forms)
• Uniformity of dosage units
• Microbial limits
• Physical parameters (hardness, friability, disintegration)
• Related substances / Impurities

We provide authenticated CoA for every batch shipped.

Yes, we provide comprehensive customs clearance support:

• HS Code Classification: Accurate tariff classification for pharmaceutical products
• Export Customs: Complete export documentation and customs formalities at origin
• Import Customs Coordination: Liaison with customs brokers at destination
• Duty Calculation: Assistance with duty and tax estimation
• Customs Queries: Resolution of any customs-related issues

Our expertise ensures smooth customs clearance with minimal delays.

We offer multiple shipping options based on product type, urgency, and destination:

• Air Freight: 5-10 days, ideal for urgent orders, temperature-sensitive products
• Sea Freight: 20-45 days, cost-effective for large volumes
• Express Courier: 3-7 days, for samples and small urgent shipments

All shipments include real-time tracking and full insurance coverage.

Yes, we provide comprehensive cold chain logistics for temperature-sensitive pharmaceutical products:

• GDP-Compliant Warehousing: Temperature-controlled storage facilities (2-8°C, 15-25°C, -20°C)
• Validated Packaging: Insulated containers, gel packs, dry ice, VIP packaging
• Temperature Monitoring: Real-time IoT data loggers throughout transit
• Temperature Mapping: Validation studies for shipping lanes
• Excursion Management: Automated alerts and deviation investigation

We maintain 100% GDP compliance for all cold chain shipments with complete documentation and temperature records.

We provide comprehensive shipment tracking:

• Real-time GPS Tracking: Location monitoring throughout transit
• Temperature Monitoring: Continuous temperature/humidity data for sensitive products
• Status Updates: Regular email/SMS notifications at key milestones
• Online Portal: 24/7 access to shipment status and documentation
• Dedicated Support: Single point of contact for shipment queries

GDP (Good Distribution Practice) is a quality system for the distribution and transportation of pharmaceutical products. It ensures that:

• Product integrity is maintained throughout the supply chain
• Temperature and storage conditions are properly controlled
• Products are protected from contamination and mix-ups
• Complete traceability and documentation is maintained
• Qualified personnel handle pharmaceutical products

We maintain 100% GDP compliance with certified warehouses, validated processes, and comprehensive documentation.

We adhere to the highest international pharmaceutical quality standards:

• WHO-GMP: World Health Organization Good Manufacturing Practices
• PIC/S: Pharmaceutical Inspection Co-operation Scheme standards
• ISO 9001:2015: Quality Management Systems
• ICH Guidelines: Q7 (API), Q8 (Pharmaceutical Development), Q9 (QRM), Q10 (PQS)
• GDP: Good Distribution Practice for logistics
• Pharmacopeial Standards: USP, BP, EP, IP compliance

Yes, we provide comprehensive stability data for all products:

• Long-term Stability: 25°C ± 2°C / 60% RH ± 5% RH for shelf-life determination
• Accelerated Stability: 40°C ± 2°C / 75% RH ± 5% RH for 6 months
• Intermediate Stability: 30°C ± 2°C / 65% RH ± 5% RH (if required)
• Photostability: ICH Q1B studies for light-sensitive products

All stability studies are conducted as per ICH Q1A(R2) guidelines in GLP-compliant laboratories.

Shelf life varies by product and formulation:

• Tablets/Capsules: Typically 24-36 months
• Syrups/Suspensions: Typically 24-36 months (unopened)
• Injections: 24-36 months depending on formulation
• Ointments/Creams: 24-36 months

We ship products with minimum 80% remaining shelf life at the time of delivery (unless otherwise agreed). Each product is accompanied by manufacturing and expiry date documentation.

To receive a detailed price quotation, please contact us with the following information:

• Product name and formulation (e.g., Paracetamol 500mg Tablets)
• Required quantity
• Destination country/port
• Preferred delivery timeline
• Packaging requirements (if any)

Our team will provide a comprehensive quotation within 24-48 hours including product pricing, shipping costs, and any applicable documentation fees.

We offer flexible payment terms based on order value and client relationship:

• New Clients: 50% advance, 50% before shipment (or 100% advance via T/T)
• Letter of Credit (LC): Irrevocable LC at sight for larger orders
• Established Clients: Credit terms up to 30-60 days (subject to credit approval)
• Payment Methods: Wire transfer (T/T), LC, Escrow (for select platforms)

All pricing is typically quoted on FOB, CIF, or CFR basis. We can accommodate other Incoterms as per client requirements.

Yes, we provide product samples for evaluation purposes. Sample policy:

• Sample Quantity: Typically 100-500 units per product
• Sample Cost: Nominal cost or free for established clients
• Shipping: Courier charges borne by recipient (or prepaid account)
• Documentation: CoA and basic product documentation included
• Delivery Time: 3-7 days via express courier

Contact us with your sample requirements and shipping address for a formal quotation.

We welcome distribution partnerships in various territories. To explore partnership opportunities:

• Contact us with your company profile and business license
• Provide details about your market reach and distribution network
• Share your experience in pharmaceutical distribution
• Indicate target markets and product categories of interest

Our business development team will evaluate the opportunity and discuss terms including:

• Exclusive or non-exclusive territory rights
• Minimum purchase commitments
• Marketing support and promotional materials
• Pricing and credit terms
• Regulatory and documentation support

Yes, we offer comprehensive Contract Development and Manufacturing Organization (CDMO) services:

• Formulation Development: New product formulation and optimization
• Analytical Method Development: HPLC method development and validation
• Stability Testing: ICH-compliant stability studies
• Technology Transfer: Process transfer to commercial manufacturing
• Commercial Manufacturing: GMP production at scale
• Regulatory Support: DMF preparation, CTD Module 3 compilation

We support OEM (Original Equipment Manufacturing), ODM (Original Design Manufacturing), and complete CDMO partnerships. Contact our custom formulations team for detailed discussions.