Manufacturing
Ace Lifecare’s core business is export of Pharmaceutical Finished Formulations and contract manufacturing for its Global Partners as per their requirement. The Finished Formulations are manufactured in plants having various global approvals (WHO-GMP & PIC/s) as well as GMP audit from various countries like Kenya, Ghana, Nigeria & Côte d’Ivoire in Africa and few countries in Caribbean/S America region and SE Asia. Ace Lifecare is fully prepared to take on the stringent global pharmaceutical standards and requirements by continuously updating their associations with associate companies.
Regulatory
The primary focus of Ace Lifecare is providing high quality products hence, technical support and documentation becomes an integral part of its operations.
Ace Lifecare has sincerely invested in this area of its business with an experienced regulatory team who prepare dossiers in various formats including CTD, ACTD and various country specific guidelines.
- 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.
- 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
- BE/BA/Dissolution profiles: We provide comprehensive BE/BA studies through collaboration with CROs in India complying requirements of individual countries. We can provide comprehensive BE studies for product registrations.
- 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