Drug Manufacturing License & Regulatory Services

A complete regulatory partner for drug manufacturers - from Central and State licensing to CDSCO approvals and dossier preparation.

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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.

Drug manufacturers in India need clearances at multiple levels - Central (CDSCO), Zonal, and State - depending on the type of approval. Here's how ZYPS supports you at each level:

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

How ZYPS Supports Drug Manufacturers

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.