FDA Regulated Industry Services
Our FDA-regulated industry services group is dedicated to supplying the quality, safety, validation, 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.
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:
Documentation writing, submissions, and remediation including 510k submissions, IDE, AER's, PMA's, remediation/resolution management, technical papers and complaint handling.
Quality Assurance and Quality Engineering
Methodology, policy, and procedure development; Gap/ Risk assessment; recalls, MDR's, and complaint handling; regulatory compliance auditing; quality systems, vendors, and IT compliance; development of complete quality systems including complaint management; deviation management; CAPA, change control; training; and document management and control.
Validation Support Processes (VSP); validation protocols (IQ, OQ, PQ); validation master plans; Lab Information Management Systems (LIMS); Standard Operating Procedures (SOP); validation executions and reports; process validation; facility qualification; Computer System Validation (CSV); equipment qualification; utility systems validation; cleaning validation; methods validation; packaging validation; IT Infrastructure; and 21 CFR Part 11.
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.
Black Diamond Networks would like to help you achieve your goals. Please email or phone us today.Email: firstname.lastname@example.org In Massachusetts call: 978-474-9980 Outside of Massachusetts call toll free: 800-681-4734 Fax: 978-470-0225 Visit us at: 23 Main Street Andover, MA 01810