Life Sciences & Technology

Our Life Sciences and Technology group is dedicated to supplying the quality, safety, validation, clinical, regulatory and compliance experts that ensure that our clients’ medical devices, medicines, delivery systems and therapeutic products are the safest and most reliable in the world. Within this technology segment, Black Diamond has rigorously and persistently sought out and recruited the most highly-specialized and proficient talent nationwide making it uniquely qualified to respond quickly and confidently to client’s critical resource needs.

Quality

  • Quality Assurance, Quality Control & Quality Systems
  • Quality Remediation, Gap Assessment & Quality Investigations
  • Risk Management
  • Post-Market Surveillance
  • Design Control
  • Process Development & Engineering
  • Internal & External Auditing
  • Compliance Engineering (US/International)

Validation

  • Validation Engineering, Documentation Development and Execution
  • Facilities, Utilities, Equipment, Process, Automation, Test Method, Analytical Method, Laboratory, Computerized Systems, Software, &  IT Validation
  • Cleaning & Sterilization; Packaging & Labeling

Regulatory 

  • Regulatory Submissions, Technical Writing & Regulatory Strategy Development
  • PMAs, 510(k)s, NDAs, ANDAs, BLAs, INDs, IDEs & other regulatory filings 
  • International Regulatory Filings, Product Registrations & Labeling

Clinical 

  • Medical Writing
  • Medical Monitoring
  • Clinical Trial Management
  • Clinical Development / Clinical Study Design
  • GCP Auditing
  • Drug Safety / Pharmacovigilance
  • Biostatisticians, Toxicologist & Clinical Scientists

Industries Served



PHARMACEUTICAL

 



MEDICAL DEVICES

 



BIOTECHNOLOGY

 

OUR PLACEMENT PROCESS
 

 

Potential Black Diamond Networks consultants are sourced  using a variety of recruitment methods including direct recruitment, consultant referrals, client referrals and internet search agents. BDN puts an emphasis on consultants sourced through direct recruitment and referrals, as these candidates have a recommendation from a known source, or are currently working on assignment in our core service market. Recruiters are required to source 50 percent or better of their contractor clientele from referrals or direct recruitment.  This is tracked by review of each contractor candidate being considered for acceptance into our consultant network. To be certified as a Black Diamond Network’s contractor, each new candidate must undergo a rigorous, multi-step qualification and review process. Only the very best make it in.

 

HOW CAN WE HELP?

We use our expertise to assist our clients with: 

  • Project Planning and Management
  • Remediation Efforts
  • Mergers & Acquisitions
  • Facility Expansions & Upgrades and Commissioning & Decommissioning
  • Technology Transfers, Scale-Up Operations, Process Optimization, and Development
  • Regulation Change and Compliance Risk Management
  • Regulatory Approvals and Product Filings
  • Clinical Trials
  • Auditing and Inspection Preparation

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