Services

Compliance

Good processes based on good SOPs are essential to compliance. HERAX offers a full range of services from compliance advisory services, revision and development of new SOPs to compliance evaluation in implementation projects.

HERAX consultants have extensive knowledge about GCP, Quality and Compliance and can assist with these services in all areas of Clinical Development.


Clinical SOP Development
IT SOP Development
Compliance Advisory
Audit Preparation
CFR 21 Part 11 assessment
Clinical SOP Development

HERAX offers preparation and revision of existing SOPs in all areas of Clinical Development. With our experience from all business areas and an effective approach to identify process steps, roles and actions, we can produce quality SOPs within reasonable time. By using our approach our client's time is focused on providing input to the SOP and ensuring that the process is correct.

IT SOP Development

ITIL, System operations, projects, maintenance and governance all requires good SOPs. HERAX can effectively create all SOPs and WIs needed in the IT department.

Compliance Advisory

HERAX employs experts with compliance experience from major pharmaceutical companies. We can advise about needed changes to existing compliance setup, and help implement them.

Audit Preparation

HERAX offers audit services on preparedness training, mock audits and follow-ups.

CFR 21 Part 11 Assessment

Are your systems in compliance with CFR 21 Part 11? HERAX offers an extensive compliance check to identify the state of our client's system and any corrective actions needed.