The Drug Controller General of India
(DCGI) has formed new Regulatory and ICH GCP guidelines. These
guidelines include: recommendations regarding structure and format of
genomic biomarker regulatory submissions; the Development Safety Update
Report (DSUR), intended to be a common standard for periodic reporting
on drugs under development among ICH regions.
In response to the new guidelines, Max Neeman
(leading Indian-based CRO) trained the Quality Assurance team and
incorporated required changes into SOPs to carry out trials for
biomarkers and stem cell trials. Extensive, timely, up-to-date training
in response to India regulatory bodies
provides for an exceptional level of knowledge regarding the most
current Indian Clinical Trial Regulations, ICH GCP guidelines and ISO
and ISMS standards.
Quality
Assurance forms an integral part of drug development to maintain the
integrity of clinical trials. Max Neeman continually trains employees
to keep current with new DCGI, ICH GCP guidelines and to seek out the
most effective actions to correct and prevent issues. Company QA
auditors have years of hands-on experience working as CRCs and CRAs
which allows for in-depth knowledge of operational aspects. Based on
this and strong SOPs, the team can provide insightful recommendations,
helping to ensure compliance and high quality results.
In addition to a comprehensive internal Quality Assurance program, Max Neeman
provides stand alone service to sponsors and clients. A full range of
clinical audit services exist from SOP preparation to advice on trial
implementation in order to maintain the highest standard of conformance
to ICH GCP regulations. Indeed, Max Neeman has successfully completed a 5th external regulatory audit for highest enrollment globally.
