Life Sciences & Technology Services

Our Life Sciences industry services group is dedicated to supplying the quality, safety, validation, regulatory, clinical 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.


Among our offerings in this area are individual specialists and project teams to assist clients with process design, protocol development, quality improvement, auditing, and operational review to achieve compliance with FDA regulations, CE marking, ICH guidelines, and other regulatory body requirements. We are particularly well suited for event driven work such as mergers, remediation efforts, CAPA's, quality system improvement plans (QSIP), response to 483's, new product releases, qualifying and validating new manufacturing equipment, and post market surveillance.


We can supply expertise in the following specific areas:

 

Regulatory Affairs
Regulatory Submissions and Strategy Development, Pre-Market Approvals/Post Market Approval, CMC Regulatory, CE Marking, NDA/IND, 510k, Country/Product Registrations, Global/International Filings.

 

Quality Assurance and Quality Engineering
Quality Remediation, Engineering, and Investigations; Gap Assessment, Risk Management, Design Control, Process Engineering, CAPA, NCR, Post-Market Surveillance (Complaint Handling and MDRs), Internal and External Auditing, Compliance Engineering (US and International).

 

Validation
Validation Engineering, Documentation and Execution; Cleaning/Sterilization, Packaging Qualification, and Validation (Facilities, Utilities, Equipment, Process, Automation, Test Method, Laboratory, CSV/SW, IT System)
 

Clinical Research and Clinical Affairs

Clinical Study Reports (CSR)/Medical writing; Clinical Trial Management; Clinical Development/ Clinical Study Design; Clinical Research Organization & Clinical Lab auditing; Clinical Scientists, Drug Safety/Pharmacovigilance, Biostatisticians, Product Registrations, Applications, Labeling & Post Approval Activities.


Black Diamond's relational approach to service allows us to treat each client as if they were our only one. As such we tailor our approach to meet each client's needs, so please ask about any particular expertise that may not be mentioned above.

Contact Us Today

Black Diamond Networks would like to help you achieve your goals. Please email or phone us today.

info@blackdiamondnet.com Call toll free: 800-681-4734  Fax: 978-470-0225 
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Submit Your Resume

Submit your resume to register with Black Diamond Networks.  Let us show you how to reach your professional goals.

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