Services

Consultation services that provide fast access to a breadth of expertise in combination product development via virtual or in-person sessions, including:

• Guidance on country-specific** regulations to strive towards a successful submission
• Key considerations to support drug delivery system selection and process development
• Recommended testing strategies§ to de-risk development activities
• Additional access to relevant combination product development and regulatory submission experience

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

• Expedited access to product information and specifications
• Product specific sessions aimed to support combination product development

*Available for select products and product systems
**Select countries available
§Testing strategy recommendations are non-exhaustive

Expand your reach with regulatory support*

Canada

• BD can provide you with a Letter of Authorization to BD Canada DMF. Make your online request here.
• 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.

China

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 products.

Europe

BD can support your preparation of a Global Safety and 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).

Japan

BD can support your registration of a combination product to the Pharmaceuticals and Medical Devices Agency (PMDA) by providing a package of documents in line with the Japanese Essential Requirements Checklist (ERCL) following the applicable Ministry of Health, Labour and Welfare Notification.

Korea

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, etc. and Korean standards.

Malaysia

BD can support your preparation, in line with the 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.

United States of America

BD can provide you with a Letter of Authorization to BD US DMF. Make your online request here.

*Available for select products and product systems
**Full offerings not shown

Access to GMP production filling assembling, and labeling for not-forhuman-use small volumes, with services including:*§

Filling

• Syringe filling in a clean atmosphere area
• Glass and plastic syringes 1 mL to 50 mL
• Terminal steam sterilization capable

Assembling

• Assembling includes pre-filled syringes with autoinjectors or needle shielding systems

Labeling as per customer input

• Labeling includes syringes and autoinjectors

*Available for select products and product systems
§ Customer samples required

We offer numerous primary container and device characterization services such as:

• Material & mechanical behaviors modelling
• Functional dimension analysis
• Various functional testing on customized systems to understand changes in performance over time
• Predictive PFS/drug analytical studies
  
• Syringe barrel & stopper performance with drug product
• Autoinjector Powerpak simulations with primary container and drug product

These studies yield data to help clients make informed decisions on primary containers and devices

Evaluate primary container and drug interaction
We provide predictive tools, subvisible particle analysis, Tungsten studies, and extractable and leachable studies to help:

• Support primary container choice
• Assess incompatibilities with tungsten, metal ion and organic leachable
• Assess Interface incompatibilities (Drug degradation/alteration of the device functionality)
•  Assess what compounds associated with primary container could be extracted into the drug product
• Evaluate combination product performance
  To assist in evaluating device and drug combination product functional performance for needle-based injection systems, safety systems, and autoinjector systems, we offer:
• Dose accuracy testing
• Injection time (in air)
• Activation and glide force testing
• Additional testing capabilities
• Assess closure integrity of the system
• We can assist in developing a holistic approach to your container closure integrity strategy for quality assurance throughout the entire product lifecycle.

We offer several methods:

• High Voltage Leak Detection
• Helium Leak Detection
• Vacuum Decay Detection
• Dye Leak Detection

*Available for select products and product systems

Our experienced team assists in developing a robust and rapid complaint handling process.

We help device teams conserve precious resources in developing and maintaining product complaint programs as well as reduce the pains of surge work

We can support customers with their market complaint management programs. We receive complaint samples, decontaminate them and execute a protocol to determine root cause of the complaint using methods such as:

• Dimension & silicone measurement
• FM/Particles visual
• SubVP evaluation / MFI and HIAC methods
• Functional & performance testings

We can support manufacturing and quality organizations with incoming inspection testing of raw materials

Incoming inspection testing can be related to mechanical performance testing, lubrication inspection, dimension measurements, or other customer requested inspections

We provide lot release testing services for primary containers and devices

• Typical lot release testing can include functional device performance testing or container closure integrity testing (CCIT)
• Lot release testing can support clients when their contract manufacturer organisation (CMO) or contract packager organisation (CPO) may not be as familiar with combination product test methods