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At Lifescience Intellipedia all export documentation & technical assistance are being provided for below activities

WHO-GMP CERTIFICATION

WHO GMP is mandatory step to move for export, we provide assistance for building up compliance as per WHO-GMP and also we help to get WHO-GMP certification from Licensing authority and the joint inspection process

DMF COMPILATION (CTD)

We provide DMF compilation on basis of data provided by API manufacturer, we also have our service as assistance for filling DMF in US and EU

We also supply open part DMF- required for dossier submission

DOSSIER COMPILATION (ACTD, CTD OR eCTD)

We provide dossier compilation on basis of data and documents provided by Drug product manufacturer. After submission of dossier we also serve assistance for related query solution till the registration or approval granted

We provide dossier for Pharmaceutical, Agrochemical, Nutraceutical, Cosmetics and Biologics formulation products

BE STUDY REPORT

We have collaboration with various CRO approved with DCGI. We can provide you BE study at very affordable cost for Generic Drug products

Also we can provide you BE study report for submission to any overseas country for Export

EXPORT REGISTRATION (Semi-regulated & regulated countries)

For export, apart from documentation support we also provide complete assistance in terms of Agent over there in importing country and plant facility approval

EXPORT NOC

For exporting Pharma products, NOC is required from CDSCO, we provide service as time bound surety to get Export NOC from CDSCO

RDA COMPLIANCE & NUTRITIONAL INFORMATION TABLE

We provide nutritional calculation and RDA compliance for food products as per the prescribed guidelines

AYUSH PREMIUM MARK AND AYUSH STANDARD MARK

We provide AYUSH standard mark and AYUSH premium mark certification for ayurvedic products

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