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Regulatory Setup

Regulatory Setup

Product Dossiers

Success of any Pharmaceutical export Company depends on strong documentation and regulatory support. At Ace Lifecare, we provide registration dossiers complying with Common Technical Dossier (CTD) & ASEAN Common Technical Dossier (A-CTD) format along with dossier formats of over 20 countries worldwide. At present we can provide ACTD/CTD dossiers for over 30 products and for rest of World countries over 65 products.

BE/BA/Dissolution profiles

We provide comprehensive BE/BA studies through collaboration with CROs in India complying requirements of individual countries. At present we can provide BE studies of 20 products with another 15 under process which will be completed by mid 2014.

Drug Master Files of APIs (DMF)

We manufacture products of highest quality and hence we provide all required documents like DMF of APIs. At present we can provide DMF for over 20 products from our reputable API suppliers

Analytical/Process Validation

With a basket of wide range of products, we are able to provide the above for almost any product you may wish to introduce in your respective country

Legalization services

We are well equipped to comply to regulatory requirements like legalization of documents (from foreign Embassies of different countries) for submission to regulatory authorities in the respective countries worldwide

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