Comprehensive services

At BD, we have built our services and capabilities around a deep understanding of the drug development process and the key objectives at each stage. Knowledgeable and responsible, our team offers the many capabilities you need beyond taking your product to market.

Right Solutions – right time

Expert capabilities at each stage

  • Preclinical
  • Phase 1
  • Phase 2
  • Phase 3
  • Commercialization and life cycle management (LCM)
  • Evaluation and selection of system components Tailored technical training or consultation on drug interactions and system selection Component-specific extractables documentation and testing Component sensitivity screening Formulation characterization and optimization Mechanical and functional feasibility testing for system selection Consultation on CMO and vendor selection, and fill/finish considerations
  • Drug launch and commercialization

    Validation and troubleshooting assistance for:

    Fill/Finish considerations Assembly Other assembly equipment rental
  • Delivery system validation System build based on component study results and drug product needs Method optimization for specific drug formulation System-based leachables study with drug product and different time points using validated methods System-based functional and performance testing conducted with drug product
  • Drug product regulatory file preparation and submission

    Delivery of comprehensive documentation packages to support validation and regulatory filing including but not limited to:

    Technical dossiers and letter of authorization to drug master files. Request your Documents online in just a few clicks Customized regulatory support and documentation on a case-by-case basis Human factors testing data Design control information External R&D summary reports Biocompatibility data
  • Life cycle management Ongoing technical and regulatory support for postlaunch and LCM TCO, CI/lean process assessment Change management assessments

Realized benefits

Delivering efficient services to ensure effective products

Each of our services is delivered intentionally and carefully to directly result in significant benefits for your product, and your company.

Services and consultation tailored to your needs

Flexible service for cost and time savings

World-class container selection and validation

An optimized packaging solution

Access to device and scientific testing experts

Reduced time to market

Combination product knowledge and testing capabilities

Component and system performance consistency

GMP-compliant labs with state-of-the-art equipment

High-quality test results, which can be leveraged in regulatory filings

Customizable protocols

Relevant and accurate results

A cross-functional, credentialed and well-trained team

Risk mitigation

Customer services

Partnership beyond products

We offer a range of services that complement our products to provide you with an optimal solution.

Technical services

Unmatched capabilities to address your development needs

Lab capabilities Testing capabilities Combination product support

State-of-the-art GMP-compliant lab

  • ICH storage capabilities
  • Elemental analysis
  • Volatile and semivolatile compound analysis
  • Organic compound analysis
  • Protein analysis
  • Particle detection and characterization
  • System functionality and performance

Comprehensive testing portfolio

  • Analytical and bioanalytical testing
  • Feasibility and optimization testing
  • System (combination product) functionality and performance testing
  • Container closure integrity testing
  • Fill/Finish services

Combination product strategy design, execution and troubleshooting

  • Extensive knowledge from partnerships that have brought hundreds of drugs to market
  • Smart testing strategies guided by our integrated system approach
  • Supportive data and documentation complying with regulatory expectations
  • Access to all relevant cross-functional subject matter experts

Regulatory guidance

Navigating you through ever-changing regulations

Our Regulatory Affairs team applies years of experience with legislative and regulatory bodies both from the pharmaceutical and medical device environments at the local, regional and international levels to smoothly guide you through regulatory submissions. 

Support in all areas

We offer a full technical, regulatory and clinical data package compliant with worldwide standards.

Registration and access

Our complete registration package includes access to technical dossiers and delivery of letters of authorization to reference U.S. and Canadian Drug Master Files.

Request your Documents  online in just a few clicks

Regulatory expertise

Our expertise spans current and upcoming ISO/IEC/EN, USP/EP/JP, ICH and other regulatory requirements for the Common Technical Document (CTD) and combination products.

Quality standards compliance

Continuously monitoring the evolution of international quality standards and regulations.

Explore our products

Products for all drug delivery needs

Are you ready?

Speak to a solution expert today about your product.