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.

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PIS-registered establishment

Gdynia, Polen

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

SIDEN 2009

Kvalitetslogg for kosttilskudd

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

FORMÅLSEGNET

Analytisk dokumentasjon

Spesialisearte metoder utføres av kvalifiserte uavhengige laboratorier når produktets dokumentasjonsplan krever det.

ISO/IEC 27001

Informasjonssikkerhet

Kundens immaterielle rettigheter og konfidensielle dokumenter styres innenfor det sertifiserte informasjonssikkerhetsrammeverket.

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.

Dokumentasjonsprotokoll

Reproduserbarhet før gjennomstrømming.

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

Prosesskontroll

Produktspesifikke kritiske prosessparametre

Analytisk frigjøring

Dokumentasjonsplan tilpasset produktet

Kontinuitet

Scale-up planning against product requirements

Styring

ISO/IEC 27001 informasjonskrypteringsrammeverk

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.
Kontraktsfestede prosjektspesifikke leveranser utformet for å støtte eierskap og kontinuitet; eksisterende Olympia-plattformer forblir særskilt regulert.

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

Utførelsesstige

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.

Beslutninger om mykkselater evalueres opp mot produktets tekniske og kvalitetsmessige krav; ingen leveringsform eller prosess garanterer et klinisk, stabilitets- eller kommersielt resultat.

HVA ER PRODUKSJON AV MYKKSELATKAPSLER

Hva er produksjon av mykkselatkapsler?

Produksjon av myke gelatinkapsler (softgel) innebærer utvikling og produksjon av en forseglet kapsel rundt et kompatibelt flytende eller halvfast fyll. Hvorvidt softgel er det rette formatet avhenger av fyllets kjemi, dosering, aktiv stabilitet, skallkompatibilitet, tiltenkt marked, emballasjekrav og kommersielle produksjonsbegrensninger. Egnethet må vurderes for det spesifikke produktet snarere enn å antas basert på 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

Siste kontrollpunkt

Iverksett 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.

Start R&D Due Diligence Revider oppskaleringsarkitektur

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

Softgel Contract Manufacturing: Buyer Questions

Hva avgjør om en myk kapsel (softgel) er teknisk egnet?

Beslutningen avhenger av flytende eller halvfaste fyllmasser, skallpolymer, forseglingssøm, eventuelt enterisk belegg, emballasje, tiltenkt holdbarhet, dosering og det tiltenkte markedet. En kategoribenevnelse eller et innledende pristilbud kan ikke fastslå kompatibilitet.

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.

Hva omfatter en mulighetsserie (feasibility review) for myke kapsler?

Den definerer produktbeskrivelsen, identifiserer kritiske spørsmål knyttet til kompatibilitet og stabilitet, fastslår hvilken dokumentasjon som kreves, og dokumenterer om myke kapsler er den rette veien å gå før formulering og oppskalering defineres.

Hvor blir programmer for myke kapsler utviklet og produsert?

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 eier formelen og prosessdokumentasjonen?

Eierskap og portabilitet for kontraktsfestede prosjektspesifikke leveranser er fastsatt i avtalen. Olympias eksisterende plattformer, gjenbrukbare metoder og tredjepartselementer forblir regulert separat.

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 / Ansvarsfraskrivelse for utdannings- og FoU-formål

Farmakokinetiske data, kliniske referanser og vitenskapelig litteratur som refereres til på denne siden, er utelukkende tilgjengelig for B2B-formulering, utdanning og FoU-formål for medisinsk personell, farmakologer og merkevareutviklere. Olympia Biosciences™ opererer utelukkende som en Contract Development and Manufacturing Organization (CDMO) og produserer, markedsfører eller selger ikke sluttprodukter til forbrukere.

Globalt regelverk og ingen helsepåstander. Ingenting på denne siden utgjør en helsepåstand, medisinsk påstand eller påstand om reduksjon av sykdomsrisiko i henhold til EU-forordning (EF) nr. 1924/2006, U.S. Dietary Supplement Health and Education Act (DSHEA) eller andre globale regulatoriske rammeverk. Disse uttalelsene og rådataene har ikke blitt evaluert av Food and Drug Administration (FDA), European Food Safety Authority (EFSA) eller Therapeutic Goods Administration (TGA). De omtalte rå aktive farmasøytiske ingrediensene (APIs) og formuleringene er ikke ment for å diagnostisere, behandle, kurere eller forebygge sykdom.

Kundens 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.