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Q1: What sterile manufacturing capabilities does Eramol offer for Phase I and Phase II clinical trials?
Eramol provides GMP sterile liquid manufacturing for 2 mL and 10 mL clinical vials, supporting early-phase programmes requiring aseptic precision and regulatory alignment.
Our new sterile facility includes aseptic isolator technology, Grade A/C cleanrooms, and terminal sterilisation capability, enabling us to handle a wide range of investigational products for Phase I and II.
This integrated approach ensures high-quality, compliant, inspection-ready batches for injectable clinical development.
Q2: What batch sizes and throughput can Eramol support for sterile vial production?
The facility is designed for 24/7 shift operation, delivering >1,000 sterile vials per day depending on formulation and fill volume.
Whether aseptic or terminally sterilised, every batch benefits from rigorous quality control, QP alignment, in-process monitoring, and validated processes.
Combined with on-site packaging, labelling, QP release, storage, and global distribution, Eramol offers a true end-to-end sterile vial manufacturing solution.
Q1: Can Eramol procure commercial medicines for clinical supply?
Yes—Eramol provides UK/EU commercial procurement for clinical trials, early-phase studies, and packaging projects.
Q2: How does Eramol ensure compliance?
Procured medicines undergo GDP control, QA/QP checks, and full documentation before production or packaging.
Q1: Does Eramol source comparators globally?
Yes—originators, biosimilars, generics, and matched placebos sourced through fully licensed channels, with complete documentation.
Q2: How does Eramol ensure authenticity?
Comparators arrive with batch traceability, CoAs, regulatory documents, and QP verification.
Q1: What storage conditions does Eramol support?
Ambient, 2–8°C, -20°C, and -80°C storage, all fully GMP monitored and backed by 24/7 environmental control.
Q2: How does Eramol ensure compliant global distribution?
Through GDP couriers, validated shippers, temperature tracking, and integration with release and packaging workflows.
Q1: Can Eramol manage global importation of IMPs and commercial medicines?
Yes—Eramol manages end-to-end EU and UK importation, including shipment oversight, customs, GDP control, and QP confirmation.
Q2: How does Eramol ensure imported product compliance?
Every import undergoes temperature monitoring, visual checks, GMP verification, and QP review before entering the supply chain.
Q1: What is included in Eramol’s QP release service?
QP services cover batch review, GMP compliance verification, documentation assessment, and final certification for both EU and UK supply.
By embedding QP oversight across manufacturing and packaging, Eramol delivers faster turnaround and reduced compliance risk.
Q2: Why choose Eramol for QP release?
Eramol offers sterile and non-sterile manufacturing, packaging, labelling, and QP release under one quality system, ensuring unified governance and accelerated timelines.
Q1: What GMP-compliant labelling services does Eramol provide?
Eramol offers single-panel, multi-panel, booklet, blinded, and randomised labelling, with late-stage customisation for global trials.
Our label application integrates directly with sterile and non-sterile manufacturing lines, improving speed and accuracy.
Q2: How does Eramol ensure global regulatory compliance for labels?
All labels undergo 100% verification, artwork approval, translation control, and QP review.
Compliance aligns with Annex 13, MHRA, and global IMP requirements, supporting smooth QP certification and global distribution.
Q1: What types of pharmaceutical packaging does Eramol offer?
Eramol provides primary and secondary packaging for both sterile and non-sterile products, including vials, blisters, kits, shippers, and bespoke assemblies.
All packaging is completed under GMP conditions, with full traceability and QA oversight to ensure regulatory-ready, inspection-quality output.
Q2: How does Eramol ensure packaging quality and compliance?
Packaging processes follow validated procedures, in-line checks, and QP-aligned documentation to meet global regulatory requirements.
As an end-to-end provider, packaging is integrated with manufacturing, labelling, and distribution for a seamless quality pathway.
Q1: What non-sterile dosage forms can Eramol manufacture?
Eramol supports a full suite of non-sterile manufacturing including tablets, capsules, and oral liquids, covering both active and placebo formulations.
With a capacity of 40,000 tablets per hour and tablet sizes from 5 mm to 25 mm, Eramol is equipped for a wide range of clinical and early commercial projects.
All production is carried out under GMP oversight, with integrated QA, regulatory support, and QP governance for guaranteed quality.
Q2: Does Eramol provide blinding, over-encapsulation, and placebo-matching services?
Yes—Eramol offers over-encapsulation, blinding (visual, taste, smell), and placebo manufacturing to support comparator studies, randomised trials, and double-blind clinical designs.
These capabilities integrate seamlessly with packaging, labelling, QP release, storage, and distribution, enabling a single-vendor, end-to-end supply-chain approach that reduces timelines and improves trial quality.
Q1: What supply-chain services does Eramol offer?
Forecasting, sourcing, packaging, labelling, QP release, storage, distribution, returns, and destruction—covering the full clinical supply lifecycle.
Q2: How does Eramol reduce study risk?
By offering true end-to-end control, combining sterile and non-sterile manufacturing, comparator sourcing, packaging, regulatory oversight, and logistics within one unified quality system.