Our Services
Ascension’s experienced consultants to assist clients in the pharmaceutical, biotechnology, medical device, and related life science industries with quality, validation, compliance, auditing, and to achieve compliance with FDA, ISO, and ICH guidelines and regulations. Our consultants’ expertise includes:
Quality Assurance & Quality Engineering
Development of complete quality systems, including complaint management, deviation management, CAPA, change control, training, and document management and control. Methodology, policy, and procedure development. Gap/Risk assessment. Recalls, MDR’s and complaint handling. Auditing to determine compliance with applicable regulations, guidelines, procedures, and policies for Part 11, quality systems, vendors, and IT compliance.
Regulatory Compliance
Writing 483 responses, documentation, and remediation. Regulatory submission document Auditing including 510(k) submissions, PMA’s, IDE, remediation/resolution management and complaint handling.
Additionally, we provide training via seminars and specific on-site training. When requested, we provide all essential consulting to achieve and maintain CGXP compliance.
Whether you are a start-up or a well-established company, we are available to assist you in all your needs related to regulatory compliance to CGXP.