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6
Best Practices
to Navigate and
Sustain
REGULATORY
LABELING
COMPLIANCE

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6 Best Practices to Navigate and Sustain Regulatory
Labeling Compliance

Regulatory Labeling
It has always been a difficult task to be compliant with the changing regulatory norms. When it comes to labeling,
the criticality doubles as it becomes necessary to not only be compliant but to even provide the correct instruction
for use (IFU). Many companies find it difficult to manage labeling regulations and also remain compliant with it.

Labeling Regulation in the pharma Industry


New avenues have opened up in the pharmaceutical industry with regards to labeling and companies are still z
gearing up to cope with these new implementations. The manufacturers who come under the regulations of the
Drug Supply Chain Security Act (DSCSA) from the FDA must achieve complete traceability by serializing their product
labels right from production until it reaches the patients. On the other hand, the EU has come up with the Falsified
Medicines Directive (FMD) which the manufacturers there need to comply with. The companies need to be
compliant with all these to reach out to the global markets.

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