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, Polonia

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

DIN 2009

Istoric de calitate pentru suplimente alimentare

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

ADECVAT DESTINAȚIEI

Dovezi analitice

Metodele specializate sunt efectuate de laboratoare independente calificate, atunci când este cerut de planul de dovadă a produsului.

ISO/IEC 27001

Securitatea informației

Proprietatea intelectuală a clientului și documentele confidențiale sunt gestionate în cadrul cadrului certificat de securitate a informației.

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.

Protocol de evidență

Reproductibilitate înaintea volumului de producție.

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

Controlul procesului

Parametri critici de proces specifici produsului

Eliberare analitică

Plan de dovezi adaptat produsului

Continuitate

Scale-up planning against product requirements

Guvernanță

Cadru de securitate a informației ISO/IEC 27001

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.
Livrabile contractuale specifice proiectului, concepute pentru a sprijini transferul dreptului de proprietate și continuitatea; platformele Olympia preexistente rămân reglementate separat.

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

Etapele Execuției

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.

Deciziile privind capsulele moi sunt evaluate prin prisma cerințelor tehnice și de calitate ale produsului; niciun format de livrare sau proces nu garantează un rezultat clinic, de stabilitate sau comercial.

CE ESTE FABRICAREA CAPSULELOR MOI

Ce este fabricarea capsulelor moi?

Fabricarea capsulelor moi (softgel) presupune dezvoltarea și producția unei capsule sigilate în jurul unui conținut lichid sau semi-solid compatibil. Adecvarea formatului softgel depinde de chimia conținutului, dozaj, stabilitatea substanței active, compatibilitatea învelișului, piața căreia îi este destinat, cerințele de ambalare și constrângerile de producție comercială. Compatibilitatea trebuie evaluată pentru produsul specific și nu presupusă pe baza categoriei.

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

Filtru Final

Inițierea procesului de Due Diligence în R&D.

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.

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

Softgel Contract Manufacturing: Buyer Questions

Ce determină dacă o capsulă moale (softgel) este adecvată din punct de vedere tehnic?

Decizia depinde de umplutura lichidă sau semi-solidă, polimerul învelișului, sigiliu, orice strat enteric, ambalaj, termenul de valabilitate țintă, doză și piața vizată. Un nume de categorie sau o cotație inițială nu pot stabili compatibilitatea.

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.

Ce include o evaluare a fezabilității pentru capsule moi (softgel)?

Aceasta definește specificațiile produsului, identifică aspectele critice de compatibilitate și stabilitate, determină dovezile necesare și consemnează dacă formatul de capsulă moale (softgel) este calea adecvată înainte ca formularea și scalarea să fie stabilite ca amploare.

Unde sunt dezvoltate și fabricate programele pentru capsule moi (softgel)?

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.

Cine deține formula și documentația de proces?

Dreptul de proprietate și portabilitatea livrabilelor contractate specifice proiectului sunt stabilite în acord. Platformele preexistente ale Olympia, metodele reutilizabile și elementele terțe rămân reglementate 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 ›

Declinarea responsabilității: Strict B2B / Cercetare-Dezvoltare (R&D) educațională

Datele farmacocinetice, referințele clinice și literatura științifică menționate pe această pagină sunt furnizate strict în scopuri de formulare B2B, educaționale și de cercetare-dezvoltare (R&D) pentru profesioniștii din domeniul medical, farmacologi și dezvoltatorii de branduri. Olympia Biosciences™ operează exclusiv ca organizație de dezvoltare și fabricație prin contract (CDMO) și nu produce, nu comercializează și nu vinde produse finite către consumatori.

Reglementări globale și absența mențiunilor de sănătate. Nicio informație de pe această pagină nu constituie o mențiune de sănătate, o mențiune medicală sau o mențiune privind reducerea riscului de îmbolnăvire în sensul Regulamentului (CE) nr. 1924/2006 al UE, al Legii privind sănătatea și educația suplimentelor alimentare (DSHEA) din SUA sau al altor cadre de reglementare globale. Aceste declarații și date brute nu au fost evaluate de Food and Drug Administration (FDA), European Food Safety Authority (EFSA) sau Therapeutic Goods Administration (TGA). Ingredientele farmaceutice active (APIs) și formulările discutate nu sunt destinate diagnosticării, tratării, vindecării sau prevenirii niciunei boli.

Responsabilitatea clientului. 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.