GRAC-LLC (Global Regulatory Affairs Consulting-LLC)

Overview

The global regulatory landscape continues to produce challenges for the pharmaceutical and medical device companies. Evolving regulatory requirements, data, document and submission standards have created a need of new and expanded skill sets for regulatory professionals.

The new regulatory professionals, in addition of their knowledge of regulations, need to integrate expertise in science and technologies, product development processes, policy and law, business and management, communication to be able to face the challenges and complexity of the new regulations at local or international level. Furthermore, they often have to consider the requirements of a range of stakeholders when defining and implementing the regulatory strategies.

To be and stay successful Pharmaceutical and Medical Device companies need to have the appropriate regulatory professionals with the adequate skills, which isn't an easy task.GRAC- LLC team has a broad base of knowledge and experience in regulatory affairs and compliance and can provide you with the appropriate regulatory and quality support to overcome and face all challenges that your company or your regulatory professionals may encounter during these changes.

Standards & Methodologies

-GAP Analysis audits: Define your current level of compliance with the appropriate quality regulations including FDA QSR , FDA GMP, ISO 13485, Japan PAL , PICs standards and Canadian Standards CMDR.

-ISO 13485 audits

-GMP audit: Identifies any non-compliances to FDA 21 CFR 211 regulatory requirements.

-Quality System audit : We perform this audit for medical device companies to identify any non-compliances to FDA QSR -21 CFR 820 regulatory requirements.

-Japanese Accreditation Audit : We perform this in compliance with PAL to help you prepare for the Japanese accreditation audit.

Full or Partial internal audits : ISO and FDA QSR (21 CFR Part 820) require that manufacturers conduct regulatory internal audits of their quality management systems. We can perform internal quality audits for you to allow you to have an independent review of your full quality system. We can either conduct partial audits where we can focus on specific areas of the quality system where you suspect non compliances occur or have occurred, or focus on areas where audits cannot be conducted by your in-house internal auditor due to possible conflict of interest.

Qualifications, Certifications, Accreditations & Licenses

GRAC-LLC (Global Regulatory Affairs Consulting-LLC) has not posted any Certifications, Accreditations or Licenses at this time.