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.

R&Dデューデリジェンスを開始する DATA ROOM / LEGAL HUB →

PIS-registered establishment

ポーランド・グディニア

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

2009年創業

サプリメント品質実績

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

目的に適合した設計

分析エビデンス

製品エビデンス計画に基づき、必要に応じて専門的な試験が有資格の独立系検査機関によって実施されます。

ISO/IEC 27001

情報セキュリティ

クライアントのIPおよび機密文書は、認証された情報セキュリティフレームワークの下で厳格に管理されます。

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.

エビデンスプロトコル

スループットに先立つ再現性の追求

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

工程管理

製品固有の重要工程パラメータ（CPP）

分析リリース

製品に最適化されたエビデンスプラン

継続性

Scale-up planning against product requirements

ガバナンス

ISO/IEC 27001情報セキュリティフレームワーク

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.
権利帰属および継続性を担保するために設計された受託プロジェクト固有の成果物です。既存のOlympiaプラットフォームは引き続き個別に管理されます。

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

実行ラダー

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.

ソフトカプセルに関する決定は、製品の技術的要件および品質要件に照らして評価されます。いかなる剤形やプロセスも、臨床的、安定性的、または商業的成果を保証するものではありません。

ソフトカプセル製造とは

ソフトカプセルの製造では、適合性のある液体または半固形の充填物を密閉カプセルで包み込み、開発・生産します。ソフトカプセルが適切な形状であるかどうかは、充填物の化学的性質、用量、有効成分の安定性、カプセル皮膜との適合性、対象市場、パッケージング要件、および商業生産上の制約によって決まります。カテゴリ名から推測するのではなく、特定の製品ごとに適性を評価する必要があります。

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

最終審査

R&Dデューデリジェンスを開始する

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.

R&Dデューデリジェンスを開始するスケールアップアーキテクチャの監査

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

Softgel Contract Manufacturing: Buyer Questions

ソフトカプセルの技術的適性を決定する要因は何ですか？

この判断は、液体または半固形の充填物、シェルポリマー、シール、腸溶性コーティング、包装、目標とする有効期間、用量、および対象市場によって異なります。カテゴリー名や初回の見積もりだけで適合性を確立することはできません。

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.

ソフトカプセルの実現可能性レビューには何が含まれますか？

製品仕様書の定義、重大な適合性および安定性に関する課題の特定、必要なエビデンスの決定を行い、処方およびスケールアップのスコープ設定の前にソフトカプセルが適切なルートであるかどうかを記録します。

ソフトカプセルプログラムの開発および製造はどこで行われますか？

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.

処方および製造プロセスのドキュメントの所有権はどちらに帰属しますか？

受託されたプロジェクト固有の成果物の所有権およびポータビリティについては、契約書に定められています。Olympiaの既存プラットフォーム、再利用可能な手法、およびサードパーティ製要素については、引き続き個別に管理されます。

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 ›

B2B / 教育・研究開発（R&D）目的の免責事項

本ページに記載されている薬物動態データ、臨床リファレンス、および科学文献は、医療従事者、薬理学者、製品開発者を対象としたB2B向けの製剤開発、教育、および研究開発（R&D）目的のみに提供されるものです。Olympia Biosciences™はCDMO（医薬品受託開発製造企業）としてのみ事業を展開しており、最終消費者向け製品の製造、マーケティング、販売は一切行っておりません。

グローバル規制および健康強調表示に関する免責事項 本ページの内容は、EU規則(EC) No 1924/2006、米国栄養補助食品健康教育法（DSHEA）、またはその他のグローバルな規制枠組みにおいて、健康強調表示、医療上の主張、または疾病リスク低減の主張を構成するものではありません。これらの記述および生データは、FDA、EFSA、またはTGAによる評価を受けておりません。本ページで言及されている原料医薬品（API）および製剤は、いかなる疾病の診断、治療、治癒、または予防を目的としたものではありません。

クライアントの責任について 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.