Softgel CDMO · Poland · Global Brand Programmes

Softgel Capsule Contract Manufacturing

Custom softgel development and contract manufacturing for dietary supplement brands: formulation, technology-transfer assessment, scale-up and packaging. Olympia Biosciences™ is a Poland-based European CDMO serving international projects, with each production route scoped to the formula, volume and named launch markets.

Påbegynd R&D Due Diligence DATA ROOM / LEGAL HUB →

PIS-registered establishment

Gdynia, Polen

PIS-registered production establishment in Gdynia, Poland (ul. Polska 20).

SIDEN 2009

Kvalitetsdokumentation for kosttilskud

17 years of manufacturing food supplements, FSMP and related services without a single quality complaint.

VELEGNET TIL FORMÅLET

Analytisk dokumentation

Specialiserede metoder udføres af kvalificerede uafhængige laboratorier, når produktets dokumentationsplan kræver det.

ISO/IEC 27001

Informationssikkerhed

Kundens IPR og fortrolige dokumenter er underlagt det certificerede informationssikkerhedsrammeværk.

Your Manufacturing Brief

What to Send Your Softgel Manufacturer

Whether you are developing a new supplement or moving an established product, these inputs help the team assess fit and define the next paid scope. Share a non-confidential summary first; confidential formula and process documents follow the agreed NDA process.

Formula or development brief: ingredient forms, active dose per capsule, intended fill mass and shell requirements.
Commercial scope: first-order capsule quantity, annual forecast, pack count and target launch date.
Named launch countries, target population, packaging and required shelf life; global distribution needs a market-by-market scope.
For technology transfer: available specifications, Master Batch Record, analytical methods, stability data and current packaging.

Dokumentationsprotokol

Reproducerbarhed før gennemløb.

We are responsible for formulation, raw-material sourcing, testing and release of every batch; IOC sp. z o.o. is the PIS-registered manufacturer.

Proceskontrol

Produktspecifikke kritiske procesparametre

Analytisk frigivelse

Dokumentationsplan tilpasset produktet

Kontinuitet

Scale-up planning against product requirements

Governance

ISO/IEC 27001 informationssikkerhedsrammework

New Development or Existing Formula

Choose the Right Starting Point

New custom softgel: scope formulation questions, target dose, fill and shell compatibility through Paid Discovery before separately commissioned physical validation.
Existing softgel: assess the transfer dossier, source specifications and process evidence to identify gaps before agreeing pilot or commercial manufacturing work.
Kontraktspecifikke leverancer udformet til at understøtte ejerskab og kontinuitet; eksisterende Olympia-platforme forbliver reguleret separat.

Paid Discovery scope, deliverables and exclusions →Production formats and MOQ reference →

Eksekveringsstige

From Softgel Formulation to Commercial Production

Brief and scope

Review the formula or concept, production volumes, markets and available evidence. Agree the appropriate development or transfer scope.

Formulation and evidence plan

Define fill–shell compatibility questions, specifications and required evidence. Paid Discovery is intellectual work; samples and laboratory work are separate.

Validation and scale-up

Commission agreed physical work, external tests or pilot runs under separate paid work orders. Use the results to decide whether to proceed or redesign.

Manufacturing and release

Commercial production follows an accepted quotation, agreed order quantity, quality requirements and payment terms. Batch testing, release and packaging follow the contracted scope.

Softgel Manufacturing · Technical Due Diligence

Evaluate Your Softgel Formula, Shell and Packaging Together

For oil-based supplements, emulsions or semi-solid fills, the purchasing question is not just whether a capsule can be filled. The development brief must connect active dose, raw-material mass, shell compatibility, processing, stability and the final pack. Active dose and total fill mass are different specification inputs.

Softgel-beslutninger evalueres i forhold til produktets tekniske og kvalitetsmæssige krav; intet leveringsformat eller processer garanterer et klinisk, stabilitets- eller kommercielt resultat.

HVAD ER FREMSTILLING AF SOFTGEL-KAPSLER

Hvad er fremstilling af softgel-kapsler?

Fremstilling af bløde gelatinekapsler (softgels) udvikler og producerer en forseglet kapsel omkring et kompatibelt flydende eller halvfast fyld. Hvorvidt softgel er det rette format, afhænger af fyldets kemi, dosis, aktiv stabilitet, skalbeskaffenhed, det tilsigtede marked, emballagekrav og kommercielle produktionsbegrænsninger. Egnetheden skal vurderes for det specifikke produkt frem for at antages ud fra kategorinavnet.

Softgel manufacturing requirements: inputs, technical review and decision gates
REQUIREMENT	YOUR INPUT	TECHNICAL REVIEW	DECISION BEFORE PRODUCTION
Fill formulation	Ingredient forms, active dose, carrier oil or semi-solid system and intended fill mass.	Solubility or suspension behaviour, viscosity, oxidation risk and fill–shell compatibility.	Define development questions before committing to a capsule specification.
Shell and capsule format	Gelatin or non-animal preference, capsule size, shape, colour and dietary restrictions.	Polymer suitability, sealing, drying and disintegration requirements for the actual fill.	Confirm the shell route by technical review, not by a generic vegan or gelatin label.
Testing and stability	Product specification, available methods, existing results and target shelf life.	Identity, potency, relevant contaminants, capsule integrity and a product-specific stability protocol.	Agree the evidence plan and separately scoped testing before making shelf-life claims.
Packaging	Bottle or blister brief, capsules per pack, distribution conditions and launch markets.	Moisture, oxygen and light protection requirements alongside capsule compatibility.	Select a packaging specification for evaluation with the finished product.
Scale-up and technology transfer	Batch records, process parameters, historical yields and forecast demand.	Documentation gaps, pilot requirements, sourcing dependencies and production economics.	Scope transfer and industrialisation before accepting a commercial production quotation.

SCROLL HORIZONTALLY TO REVIEW MANUFACTURING REQUIREMENTS

Endelig vurdering

Iværksæt R&D Due Diligence.

Planning a new softgel supplement or a manufacturing transfer? Send a non-confidential brief with target dose, order quantity, packaging, launch countries and timing. The team will assess fit and define the appropriate paid scope before production is quoted.

Påbegynd R&D Due Diligence Audit af opskaleringsarkitektur

Evidence-led format selection | PIS-registered production establishment in Gdynia, Poland (ul. Polska 20) | qualified analytical evidence

Softgel Contract Manufacturing: Buyer Questions

Hvad afgør, om en softgel er teknisk hensigtsmæssig?

Beslutningen afhænger af det flydende eller halvfaste fyld, skalpolymeren, forseglingen, eventuel enterosagte, emballagen, den tilsigtede holdbarhed, dosis og det tiltænkte marked. En kategoribetegnelse eller et indledende tilbud kan ikke fastslå kompatibiliteten.

What is the minimum order quantity for softgel contract manufacturing?

Use the Production Formats & MOQ Reference as the starting point. The accepted order quantity must be confirmed for the formulation, shell, batch configuration and packaging. Specify both capsule count and finished-pack count in your enquiry; they are not interchangeable.

Hvad indeholder en softgel-feasibility-gennemgang?

Den definerer produktoplægget, identificerer kritiske spørgsmål om kompatibilitet og stabilitet, fastlægger hvilken evidens der kræves, og dokumenterer, hvorvidt softgel er den rette vej, før formulering og optrapning tages op til vurdering.

Hvor udvikles og fremstilles softgel-programmer?

We are responsible for formulation, raw-material sourcing, testing and release of every batch; IOC sp. z o.o. is the PIS-registered manufacturer.

Can I transfer an existing softgel formula to a new manufacturer?

An existing formula can enter a technology-transfer assessment. Provide specifications, a Master Batch Record, raw-material requirements, analytical methods, available stability results and packaging details under the agreed confidentiality process. Transfer scope, missing evidence and any pilot work must be agreed before production is committed.

Hvem ejer formlen og procesdokumentationen?

Ejerskabet og overdrageligheden af aftalte, projektspecifikke leverancer fastlægges i aftalen. Olympias eksisterende platforme, genanvendelige metoder og tredjepartselementer forbliver underlagt separate vilkår.

What determines the cost of custom softgel capsule manufacturing?

Key inputs are ingredient forms and quantities, fill mass, shell system, order volume, testing, packaging and target-market requirements. Development, physical validation, external testing and production are separately scoped. A production price requires current costing and an accepted quotation; a development fee is not a per-capsule production price.

Can I request gelatin or vegetarian softgel capsules?

Include your animal-origin exclusions and shell preference in the brief. Suitability must be confirmed against the fill, process and product requirements. A vegetarian or vegan positioning must be supported by the agreed material documentation; it is not established by the capsule name alone.

How long does a softgel development or production-transfer project take?

Timing depends on documentation readiness, formulation work, material availability, validation, testing and packaging. Share your target launch date and existing evidence so the team can identify dependencies. No fixed production lead time or shelf life is promised before technical and commercial scope is agreed.

Softgel Manufacturer Due Diligence

Global CDMO PortfolioEXPLORE ›Production Formats & MOQ ReferenceEXPLORE ›Formulation and Delivery-System TechnologyEXPLORE ›Supplement Manufacturing for Physician-Led BrandsEXPLORE ›Production Scale-Up and Technology TransferEXPLORE ›Formula IP and ConfidentialityEXPLORE ›

Strengt B2B / Uddannelsesmæssig R&D-ansvarsfraskrivelse

De farmakokinetiske data, kliniske referencer og den videnskabelige litteratur, der refereres til på denne side, stilles udelukkende til rådighed til B2B-formulering, uddannelsesmæssige formål samt R&D for læger, farmakologer og brandudviklere. Olympia Biosciences™ opererer udelukkende som en CDMO og fremstiller, markedsfører eller sælger ikke færdige forbrugerprodukter.

Global regulering & ingen sundhedsanprisninger. Intet på denne side udgør en sundhedsanprisning, medicinsk anprisning eller anprisning om sygdomsrisikoreduktion i henhold til EU-forordning (EF) nr. 1924/2006, U.S. Dietary Supplement Health and Education Act (DSHEA) eller andre globale regulatoriske rammer. Disse erklæringer og rådata er ikke blevet evalueret af Food and Drug Administration (FDA), European Food Safety Authority (EFSA) eller Therapeutic Goods Administration (TGA). De rå aktive farmaceutiske ingredienser (APIs) og formuleringer, der diskuteres, er ikke beregnet til at diagnosticere, behandle, helbrede eller forebygge nogen sygdom.

Klientens ansvar. The B2B client who commissions a formulation from Olympia Biosciences™ is responsible for market-specific regulatory compliance, health claim authorisation, labelling and marketing of its finished product, as defined by the applicable agreement.