FDA consulting services are those services that are offered by independent, mostly private companies in helping to meet FDA requirements. FDA consulting services are offered to organizations that have to meet FDA regulatory requirements. Many companies across the US and many other parts of the world specialize in offering FDA consulting services and these are often the main business for these organizations.
Why do companies offer FDA consulting service?
FDA consulting services are offered because most organizations find the maze of FDA regulation too complex, confusing and time consuming. FDA consulting services are an easy way out for these organizations, which can leave the work of meeting regulatory requirements to FDA consulting services and concentrate on their core areas of business.
What do FDA consulting services do?
FDA consulting services usually carry out all tasks associated with and required for meeting FDA regulatory requirements. While they may not be involved in the business per se, they help in the documentation part, because this is where their help is required. FDA consulting services help companies in achieving and maintaining all aspects of FDA compliance. This is done for a fee, of course, and is considered legal outsourcing.
In what areas are FDA consulting services offered?
Most FDA consulting services companies offer consulting relating to everything about FDA regulation, although some FDA consulting services companies do so only in select, specialized areas. The services offered by FDA consulting usually include the following:
- Helping before,during and after an FDA inspection
- FDA 510(k) Submissions
- Audits and inspections
- Audits and gap analysis
- Writing Standard Operating Procedures (SOPS) forms and reports
- Form 483 and responses
- Responses to Warning Letters
- Investigational Device Exemption (IDE) submissions
- Serious Adverse Event Reporting
- Medical Device Reporting
Many FDA consulting services companies offer advice on drugs, dietary supplements, clinical trials, food and tobacco, and medical devices. They also carry out complex tasks like QSR reviews, GCP, GMP, GLP audits, New Drug Application (NDA), Biologic License Application (BLA), Abbreviated New Drug Application (ANDA) and Premarket Approval (PMA), as well as remediation for companies that have to respond at short notice to compliance issues raised by the FDA.