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 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 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
Black Diamond Networks would like to help you achieve your goals. Please email or phone us today.Email: email@example.com Call toll free: 800-681-4734 Fax: 978-470-0225