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Regulatory Compliance

Powering risk-free compliant operations

Regulatory Compliance

Regulatory compliance requirements are increasing dramatically in every industry. These standards have grown increasingly sophisticated over time. Companies must maintain local, national, and worldwide compliance requirements. Failure to comply might result in significant financial losses and harm your company’s reputation.

At i3 infotek, our experts ensure that you satisfy your regulatory compliance needs. To advocate for and execute the proper solutions, we closely monitor governing and upcoming industry rules, regulatory needs, and compliance requirements. Our three critical service roles are as follows:

  • Strategic Role – Assist businesses in anticipating and adhering to regulatory change.
  • Efficiency Role – Provide cost reductions by acting as an expanded team of professionals.
  • Solution Expert Role – Create and implement contextual solutions to meet regulatory requirements.

Key Industry Focus

i3 infotek provides pharmaceutical, medical device, healthcare, and biotech companies with global regulatory, compliance, quality assurance, and auditing services. These are some examples:

  • Regulatory and Compliance Strategy
  • Product Application Formulation and Review
  • Preparation of Briefing Documents
  • Investigational Site Audits Label Development and Review
  • Audits of GMP/GLP/GCP

Organizations are taking a more thorough approach to compliance due to the importance of reconciling regulatory requirements with internal efficiencies. Our Validation and Regulatory Compliance consulting group offer quality systems and compliance services. We can help your firm with various issues, including regulatory compliance with rules such as 21 CFR Part 11.

Our Compliance Services include the following:

  • Clinical study compliance
  • 21 CFR Part 11
  • Sarbanes-Oxley
  • Compliance and Quality Systems

LEAN in-house teams:
In-house LEAN teams: Using our specialists minimizes the issues associated with hiring FTEs and allows your current team to focus on strategic priorities.

In-depth knowledge:
Our extensive industry knowledge and subject matter expertise have benefited customers. To provide proactive help to customers, our specialists are up to date on the newest compliance processes, policies, and procedures.

Systematic best-practice approach:
Our specialists use a step-by-step systematic best-practice approach to every regulatory and compliance need.

Connect with our team

We will be happy to assist you.