>

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 실사 착수DATA ROOM / LEGAL HUB →

PIS-registered establishment

폴란드 그디니아

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

2009년 설립

건강기능식품 품질 이력

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

FIT-FOR-PURPOSE

분석적 근거

제품 근거 계획에 따라 요구되는 경우, 자격을 갖춘 독립된 시험기관을 통해 전문 분석법이 수행됩니다.

ISO/IEC 27001

정보 보안

고객의 지식재산권 및 기밀 문서는 인증된 정보 보안 체계 하에 관리됩니다.

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.

검증 프로토콜

생산량보다 우선하는 재현성.

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

공정 관리

제품별 핵심 공정 파라미터(CPP)

출하 분석

제품 맞춤형 근거 자료 확보 계획

연속성

Scale-up planning against product requirements

거버넌스

ISO/IEC 27001 정보보호 체계

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.

  • 소유권 및 지속성 유지를 위해 설계된 계약 기반 프로젝트별 산출물입니다. 기존 Olympia 플랫폼은 별도로 관리됩니다.

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

실행 단계

From Softgel Formulation to Commercial Production

01

Brief and scope

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

02

Formulation and evidence plan

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

03

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.

04

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.

연질캡슐 관련 결정은 제품의 기술적 및 품질 요구사항에 기반하여 평가되며, 어떠한 제형이나 공정도 임상적, 안정성 또는 상업적 결과를 보장하지 않습니다.

연질캡슐 제조란

연질캡슐 제조란 무엇인가요?

연질캡슐 제조는 호환되는 액상 또는 반고상 내용물 주변으로 밀봉된 캡슐을 개발 및 생산하는 과정입니다. 연질캡슐이 적합한 제형인지는 내용물의 화학적 특성, 용량, 유효성분 안정성, 껍질 호환성, 목표 시장, 포장 요구사항 및 상업 생산 제약 조건에 따라 달라집니다. 카탈로그 이름만으로 단정 짓지 않고 특정 제품에 대한 적합성을 반드시 평가해야 합니다.

Softgel manufacturing requirements: inputs, technical review and decision gates
REQUIREMENTYOUR INPUTTECHNICAL REVIEWDECISION BEFORE PRODUCTION
Fill formulationIngredient 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 formatGelatin 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 stabilityProduct 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.
PackagingBottle 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 transferBatch 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

최종 관문

R&D 실사(Due Diligence) 시작

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 실사 착수스케일업 아키텍처 감사

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

Softgel Contract Manufacturing: Buyer Questions

연질캡슐의 기술적 적합성을 결정하는 요인은 무엇인가요?
액상 또는 반고상 내용물, 껍질 고분자, 실링, 장용 코팅 여부, 포장, 목표 유통기한, 용량 및 타겟 시장에 따라 결정됩니다. 카테고리명이나 초기 견적만으로는 상호 호환성을 확정할 수 없습니다.
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.
연질캡슐 타당성 검토에는 어떤 내용이 포함되나요?
제품 기획서 정의, 핵심 호환성 및 안정성 검토 사항 식별, 필수 입증 자료 확정, 그리고 제형화 및 스케일업 범위 설정에 앞서 연질캡슐 적용의 타당성을 최종 기록합니다.
연질캡슐 프로그램은 어디서 개발 및 제조되나요?
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.
포뮬러와 공정 문서의 소유권은 누구에게 있습니까?
계약된 프로젝트별 산출물의 소유권 및 이전 가능성은 계약서에 명시되어 있습니다. Olympia의 기존 플랫폼, 재사용 가능한 방법 및 제3자 요소는 별도로 규정됩니다.
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 전용 / 교육 및 R&D 면책 조항

본 페이지에 언급된 약동학 데이터, 임상 참고 자료 및 과학 문헌은 의료 전문가, 약리학자 및 브랜드 개발자를 위한 B2B 제형 연구, 교육 및 R&D 목적으로만 제공됩니다. Olympia Biosciences™는 CDMO(위탁개발생산)로서만 운영되며, 소비자용 완제품을 제조, 마케팅 또는 판매하지 않습니다.

글로벌 규제 및 건강 관련 주장 면책 본 페이지의 어떠한 내용도 EU 규정(EC) No 1924/2006, 미국 건강기능식품 교육법(DSHEA) 또는 기타 글로벌 규제 체계의 의미 내에서 건강 관련 주장, 의학적 주장 또는 질병 위험 감소 주장을 구성하지 않습니다. 이러한 진술 및 원시 데이터는 FDA, EFSA 또는 TGA의 평가를 받지 않았습니다. 논의된 원료 의약품(API) 및 제형은 질병의 진단, 치료, 완치 또는 예방을 목적으로 하지 않습니다.

고객의 책임 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.