APIs & Intermediates
Customise your product
- Route options, assay & impurity profile; polymorph/PSD (D90) targets
- Residual solvents, water (KF), heavy-metal limits; stability by ICH zone
- Tech transfer packs + process safety summary (where needed)
Branding & Packaging
- HDPE/Fiber drums with double liners; nitrogen flush if required
- COA, MSDS & retest date on label + QR lot traceability
- Tamper seals; palletised and shrink-wrapped
Sustainability & Compliance
- ICH Q7 / WHO-GMP; DMF/ASMF support where available
- Solvent recovery % & ETP/ZLD declarations; REACH (when applicable)
Finished Dosage Forms – OSD & Liquids
Customise your product
- Strengths, release profile (IR/MR), tablet/capsule shapes & colours
- Excipients (gelatin-free/vegan, sugar-free), taste-masking & viscosity targets
- Stability program & shelf-life proposal (Zone II–IVb)
Branding & Packaging
- Blister (Alu-Alu/Alu-PVC/PVdC), bottles (HDPE/PET), sachets; CR closures
- Cartons/IFUs with market-specific panels; serialization/aggregation where required
- Ship tests (drop/compression) & pack size optimisation
Sustainability & Compliance
- 21 CFR 210/211 cGMP; process validation IQ/OQ/PQ
- FSSAI/dietary supplement labels for nutraceuticals (if applicable)
Sterile & Lyophilised (Injectables/Ophthalmics)
Customise your product
- Fill volume, vial/ampoule/syringe sizes; lyo cake profile & cycle
- Filters, stoppers & seals; preservative systems (if used)
- Terminal sterilisation vs aseptic process choice
Branding & Packaging
- Tyvek®/medical paper pouches or trays; carton/IFU with storage icons
- Batch records with media fill & sterility results; tamper seals
- Cold-chain shippers with calibrated data loggers (2–8 °C/–20 °C)
Sustainability & Compliance
- EU GMP Annex 1, ISO 11135/11137/17665, USP <788>/<85>
- SAL 10⁻⁶ documentation; bioburden & endotoxin limits
Medical Devices & Disposables
Customise your product
- Materials (PP/PE/PC/TPU/latex-free), sizes & performance specs (burst/flow)
- Colour codes, graduations, catheter lengths; OEM sets & kitting
Branding & Packaging
- UDI/GS1 labels, symbols per ISO 15223-1; IFU localisation (multi-lingual)
- Sterile barrier (pouch/tray) with EO/Gamma release; shelf-life claim on label
Sustainability & Compliance
- ISO 13485, Risk Mgmt ISO 14971, Usability IEC 62366
- ISO 10993 biocompatibility & E&L where applicable
Diagnostics (IVD – LFIA/ELISA/PCR)
Customise your product
- Analyte & sample type; sensitivity/specificity targets; cut-offs & LoD
- Controls/calibrators; buffer formulations; swabs/VTMs
Branding & Packaging
- Kit box with cassettes/plates/reagents/pipettes; IFU, QC charts & lot cards
- Storage labels (2–8 °C/15–25 °C); tamper seals; QR for result app (optional)
Sustainability & Compliance
- IVDR 2017/746 tech file support; CLSI verification plan
- Real-time/accelerated stability; transport validation for cold chain
Biotech Reagents & Lab Consumables
Customise your product
- Enzyme activity (U/mg), buffer pH/ionic strength, nuclease-free specs
- Tips/tubes/plates: resin grade, RNase/DNase-free, sterility (gamma)
Branding & Packaging
- Aliquot sizes & vial type; low-bind plastics; dry-ice/ice-pack shippers
- COA, MSDS & lot trace; quick-start cards with QR protocols
Sustainability & Compliance
- TSE/BSE-free statements; endotoxin limits (if applicable)
- REACH/SVHC where relevant; waste & returnable shipper options
Packaging Components (Vials, Ampoules, Stoppers, Blisters)
Customise your product
- Glass Type I/II/III, amber/clear; neck & finish; elastomer (bromobutyl/fluoropolymer)
- Blister films (PVC/PVdC/Aclar/Alu-Alu), foil gauges & barrier targets
Branding & Packaging
- Nest/tub or tray; sterile/ready-to-sterilise; peel pouches with lot labels
- Colour-coded seals, embossed logos; ship-safe crates with partitioners
Sustainability & Compliance
Change-control & traceability to raw lots; recyclability statements
DMF Type III, USP/EP material conformity; E&L studies
