You may need to urgently compile regulatory dossiers for submissions in new markets or for license renewal in existing markets. Or, there could be old products, which do not have ICH-CTD or a CTD of specified regional format and you wish to get it done at low cost, quickly. Or there could be critical Health Authority commitments leading to update of regulatory documents. On such business needs, why wait, when the business goals can still be achieved with the same consistency, speed, accuracy, at a lower cost, without hiring/training additional staff on such short-term business priorities. 

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Most Health Authorities require the Marketing Authorization Holder to have System and Infrastructure for Pharmacovigilance Compliance. Non-submission of ADR Reports on the marketed products, non-submission of PSUR, poor quality reports or insufficient information are critical Health Authority findings during audits. Will Out-Sourcing of PSUR or ADR Reporting Help? 

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There could be old products, which do not have ICH-CTD or a CTD of specified regional format and you wish to get it done at low cost, quickly. Or, there could be critical Health Authority commitments leading to update of regulatory documents. 

On such business needs, why wait, when the business goals can still be achieved with the same consistency, speed, accuracy, at a lower cost, without hiring/training additional staff.
Read More@www.ratransintegra

Market Entry@Transintegra

If lack of resource, high cost, or lack local expertise are preventing the decision to enter Indian Market, perhaps you may plan it now. 


At Transintegra Healthcare, we could provide the entire range of support for Entry into Indian Market and for Maintenance of Products in the Indian Market. We have a full team of regulatory, clinical development, medical affairs, legal and marketing experts, to assist in registration and launch of products in Indian markets. ​ 

There could be issues of higher cost, delayed milestones, lack of regulatory transparency and accurate strategy, lack of quality and compliance or transparency and visibility of clinical project progress that is hurting your Clinical Trials outcomes in India. 


We have an effective leadership team bringing the experience of Clinical Trial management, operations and documentation from the Global Pharma Giants.

Read More@www.cdtransintegra

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