Sushen Medicamentos Pvt. Ltd.

About

Sushen is a Building Partner for Global Pharma companies.

1. Product Management Services (Inception to Execution) –
a. Pharmaceutical Plant Design – as per requirements from – WHO-GMP, USFDA, UKMHRA, PICS and other Local regulatory requirements
b. Implementation of the plant
c. We also expertise in procurement, installation & qualification for complete production equipment and machineries. Conduct FAT for the same.
d. Engineering services and implementation like HVAC and clean room panel system.
e. Preparation of the above with protocols such as URS, DQ, IQ, OQ, PQ.
f. Auditing for up-gradation and expansion, along with Capacity balancing , Product Registration Documentation (CTD), Documentation system set-up, update and upgrade, resolving cGMP problems and issues. Also ensuring the cGMP compliance.
g. First Commercial Batch Trail
h. Standard Operating Procedures for Documentation

2. Formulation and Development Services along with Tech Transfer-
a. Development for Oral Solid Dosage forms
b. Stability Study Management
c. In-Vitro Dissolution Studies
d. Organizing BA/BE Studies

We accomplish the above services through the use of latest cutting edge technologies and equipment in optimal time frame. Sushen has a state of the art Laboratory and Scale-up for FnD setup which is WHO-GMP certified, approved by DSIR of India and also designed as per USFDA and EU GMP norms. Sushen is a team of experienced engineers, pharmacists and other proactive team members with more than two decades of experience in this field.

SUSHEN assists various pharma companies in running operations worldwide, especially in US, Europe, CIS, Middle East, Latin America, East & West Africa and South East Asian countries along with India. We have executed more than 40+ projects across the world.

Keywords

pharmaceutical project management services, turnkey operators, contract research activities, analytical services, gmp related services, training, contract manufacturing

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