DRUG FOR MANUFACTURER

A concise overview for drug manufacturers detailing production processes and guidelines.

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At ZYPS, we assist manufacturers in overcoming obstacles by developing robust regulatory strategies and creating clear dossiers for filing applications for drug product approval. Our team of experts represents clients at SEC meetings, ensuring unanimous approvals and permissions. With continuous guidance, meticulous follow-ups, and additional services such as clinical trial management and medical writing, we facilitate a smooth process for our clients to obtain successful approvals/permissions and apply for licenses.

CENTRAL – CDSCO

Investigational New Drug (IND)
New Drug Approval (NDA)
BE Studies

BE NOC for export
Special code/Neutral Code for export
SEC meetings

Toxicity Studies
Subsequent New Drug Approval (SND)
Medical Writing

ZONAL – CDSCO

Test License
Export NOC
Dual NOC

STATE – FDA

Manufacturing License
Form 29 for Test Batch
Wholesale License

FOR MANUFACTURER

In the realm of pharmaceuticals, navigating the complex landscape of regulatory compliance and approvals is a critical aspect of drug manufacturing. At ZYPS, we specialize in providing comprehensive support to manufacturers, guiding them through the intricacies of regulatory processes to ensure successful product approvals.