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.

启动研发尽职调查 DATA ROOM / LEGAL HUB →

PIS-registered establishment

波兰格丁尼亚

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

始于 2009

膳食补充剂质量记录

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

契合用途

分析证据

根据产品证据计划的要求，专业方法由具备资质的独立实验室执行。

ISO/IEC 27001

信息安全

客户知识产权和机密文件在经认证的信息安全框架内受到保护。

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.

证据协议

重现性优先于产能。

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

过程控制

产品专用的关键工艺参数

分析放行

与产品相匹配的证据计划

生产连续性

Scale-up planning against product requirements

合规治理

ISO/IEC 27001 信息安全框架

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.
合同约定的项目特定交付物，旨在支持技术所有权与工艺连续性；原有的 Olympia 平台仍受独立条款管辖。

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

执行阶梯

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.

软胶囊方案需根据产品的技术与质量要求进行评估；没有任何剂型或工艺能够保证特定的临床、稳定性或商业结果。

什么是软胶囊制造

什么是软胶囊制造？

软胶囊制造围绕相容的液体或半固体填充物开发并生产密封胶囊。软胶囊是否为正确剂型，取决于填充物化学性质、剂量、活性成分稳定性、外壳相容性、目标市场、包装要求以及商业生产限制。必须针对特定产品评估其适用性，而不能仅凭品类名称盲目假设。

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

最终准入

启动研发尽职调查。

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.

启动研发尽职调查审核规模化架构

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

Softgel Contract Manufacturing: Buyer Questions

软胶囊在技术上是否适用，取决于哪些因素？

该决策取决于液态或半固态内容物、囊壳聚合物、封口、任何肠溶包衣、包装、目标货架期、剂量及目标市场。仅凭品类名称或初步报价无法确立其相容性。

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.

软胶囊可行性评审包含哪些内容？

它负责明确产品简报、识别关键的相容性与稳定性问题、确定所需的证据支持，并在界定配方与放大生产范围之前，论证软胶囊是否为适宜的路径。

软胶囊项目的研发与生产是在哪里进行的？

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.

配方和工艺文档的所有权归谁所有？

合同中项目特定的交付成果的所有权和可转移性在协议中有明确规定。Olympia原有的平台、可复用方法及第三方要素仍受单独条款约束。

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 ›

严格 B2B / 教育研发免责声明

本页面引用的药代动力学数据、临床参考文献及科学文献，仅供医疗专业人士、药理学家及品牌开发商用于 B2B 配方研发、学术教育及研发目的。Olympia Biosciences™ 仅作为合同研发生产组织 (CDMO) 运营，不生产、营销或销售任何消费类终端产品。

全球监管与健康声明免责声明 本页面内容均不构成欧盟第 1924/2006 号条例 (EC)、美国《膳食补充剂健康与教育法》(DSHEA) 或其他全球监管框架所定义的健康声明、医疗声明或疾病风险降低声明。上述声明及原始数据未经美国食品药品监督管理局 (FDA)、欧洲食品安全局 (EFSA) 或澳大利亚药品管理局 (TGA) 评估。文中讨论的原料药 (APIs) 及配方不用于诊断、治疗、治愈或预防任何疾病。

客户责任声明 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.