BD PartnerPath™ Program

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BD YourPath™ Program

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디바이스와 약물 융복합
제품 테스트​

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소규모
충진과 조립​

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허가 지원
서비스​

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그 외 서비스
(ZebraSci)

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PRODUCT DEVELOPMENT SUPPORT

Capabilities that simplify complexities

By partnering with BD for strategic support, you can minimize risk while avoiding delays in combination product development.

BD Neopak™ Glass Prefillable Syringe

The BD Neopak™ Glass Prefillable Syringe platform features advanced technologies to meet the highest expectations of leading biopharmaceutical companies. The BD Neopak™ Glass Prefillable Syringe is available in both 1-mL and 2.25-mL formats.

BD Intevia™ 1ml Disposable Autoinjector

The BD Neopak™ Glass Prefillable Syringe platform features advanced technologies to meet the highest expectations of leading biopharmaceutical companies. The BD Neopak™ Glass Prefillable Syringe is available in both 1-mL and 2.25-mL formats.

Consultation

Fast access to a breadth of expertise via virtual / face-to-face sessions

Guidance on country-specific regulations to strive towards a successful submission

Key considerations to support drug delivery system selection and

Recommended testing strategies to de-risk development activities a

Additional access to relevant combination product development and regulatory submission

Consultation

Fast access to a breadth of expertise via virtual / face-to-face sessions

Guidance on country-specific regulations to strive towards a successful submission

Key considerations to support drug delivery system selection and

Recommended testing strategies to de-risk development activities a

Consultation

Fast access to a breadth of expertise via virtual / face-to-face sessions

Guidance on country-specific regulations to strive towards a successful submission

Key considerations to support drug delivery system selection and

Recommended testing strategies to de-risk development activities a

Additional access to relevant combination product development and regulatory submission

Consultation

Fast access to a breadth of expertise via virtual / face-to-face sessions

Guidance on country-specific regulations to strive towards a successful submission

Key considerations to support drug delivery system selection and

Recommended testing strategies to de-risk development activities a

Additional access to relevant combination product development and regulatory submission

Training

Accelerated training on BD offerings via virtual / face-to-face sessions

Expedited access to product rationale, product specifications, and packaging rationale.

Product specific sessions aimed to support combination product developmentd

BD PartnerPathTM Program

제약 조직의 개발 프로세스 지원

  • 디바이스 선택 과정을 유연하고 간소화하는 데에 도움이 되는, 개발단계 작업을 위한 소량**의 약물 전달 시스템 구성요소
  • 약물 전달 솔루션에 관한 BD 전문성을 기반으로 약물 전달 필요조건을 위해 추천되는 1차용기(primary container)2차 주입 보조 디바이스(secondary injection support devices) 동정
  • 융복합 제품 개발과 허가 서류 준비를 돕는 선제적인 문서 전달
  • 1차 용기 및 2차 주입 보조 디바이스와 융복합 제품 개발에서 기술적 문제 해결 지원
  • 융복합 제품 개발 관련 정보와 위험 제거를 돕는 BD PartnerPath™ 전달 시스템 연구개발 자료±

**멸균 포장 구성에서 최소 구매 수량

±자료와 서비스는 특정 BD 제품과 제품 구성에 사용 가능

Let BD help you succeed in system integration with BD Neopak™ Glass Prefillable Syringe and BD Intevia™ 1ml Disposable Autoinjector.

Product Engineering & Device Testing

BD is here to support you in your drug-device product develop process in system integration through various product engineering and device testing services.

Consultation

Fast access to a breadth of expertise via virtual / face-to-face sessions

Guidance on country-specific regulations to strive towards a successful submission

Key considerations to support drug delivery system selection and

Recommended testing strategies to de-risk development activities a

Training

Accelerated training on BD offerings via virtual / face-to-face sessions

Expedited access to product rationale, product specifications, and packaging rationale.

Product specific sessions aimed to support combination product developmentd

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BD can support your preparation, in line with Malaysian Guideline on Drug-Device Combination Products, of an application to the Malaysian Medical Device Authority (MDA) to obtain an endorsement letter of ancillary component for registration of your combination product.
BD can support your registration of a combination product to Pharmaceuticals and Medical Device Agency (PMDA) by providing a package of documents in line with Japanese Essential Requirements Checklist (ERCL) following the applicable Ministry of Health, Labor and Welfare Notification.
BD can provide you with a Letter of Authorization to BD Canada DMF. In support of your DEL (Drug Establishment License), BD will submit to Health Canada a GMP Clearance dossier for foreign manufacturers for BD and BD-subcontracted sterilization sites.
BD can provide you with a Letter of Authorization (LoA) to applicable BD China DMF in the scope of co-evaluation of BD drug packaging material with your combination product.
BD can support your registration of a combination product by providing a Korean Technical Document in line with Korean guidelines on examining documents for sterilized needles included in drugs, and Korean standards.
BD can provide you with a Letter of Authorization to BD US DMF.
BD can support your preparation of a Global Safety & Performance Requirements (GSPR) dossier for submission to an EU Notified Body (NB) in view of obtaining a Notified Body Opinion in line with article 117 of the Medical Device Regulation (MDR).

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BD Services & Solution


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BD Neopak™ Glass Prefillable Syringe

The BD Neopak™ Glass Prefillable Syringe platform features advanced technologies to meet the highest expectations of leading biopharmaceutical companies. The BD Neopak™ Glass Prefillable Syringe is available in both 1-mL and 2.25-mL formats.

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