Regulatory Assistance

LexaMed provides regulatory compliance consulting services for clients from the pharmaceutical, medical device and nutritional supplement companies. LexaMed can assist in all areas of medical device, pharmaceutical and related industry compliance activities, including consulting on compliance and remediation action plans and strategies, assisting in new product submissions and registrations - FDA, EPA, EU, and conducting compliance audits against CFR 820, 210/211, 111, ISO 13485, 17025, Q7A, etc.  LexaMed can also generate data in our ISO 13485 certified laboratory to support product submissions.

Compliance Action Plans (CAP) and Management

►483 Observations and warning letter responses

►Structure Compliance Action Plans

►Experience with consent decree and CAP

   management

►Experience interacting with FDA

►Integrates program with client resulting in internal

   sustainability

 CAP Execution: Consulting

Teams of experienced consultants can address any situation with technically competent, proactive and comprehensive solutions:

►Validation

►Sterilization

►Microbiology & Chemistry

►Environmental Monitoring

►Training

►Audits

►Quality Management Systems

►Regulatory Affairs
CAP Execution:  Laboratory Support

ISO certified laboratory operation supports CAP remediation efforts:

►Microbiology /Chemistry

►Packaging

►D-value and z-value determinations

►Disinfectant Efficacy and Antimicrobial

   Effectiveness Testing

►Microbial Limits

►Container Closure Integrity (CCI)

►Customized projects

CAP Sustainability:

Operational Effectiveness Process (OEP)

OEP is an interactive, unique process designed to capitalize on operational capabilities:

►Disciplined decision making and resource

   focusing

►Defining Key Performance Indicators (KPI)

►Manage organizational change

►Assess CAPA effectiveness

►Establish process capabilities

LexaMed also has experience in direct interaction with FDA, EPA, and EU in support of client submissions and filings:           ►510(k)

                                                        ►Establishment Registration

                                                        ►Product Listings

                                                        ►Disinfectant Registrations