A leading player ,reliable ,cost effective and pragmatic solution provider in compliance with regulatory bodies, GXP and delivers desired quality and technical consultancy services to the Pharmaceutical, Food And allied industries to ensure Designing, qualifying ,Commissioning, Operations,Trainings and documentation as per the legal, safety and cGXP norms.
To achieve our vision we will strive to:
Our guiding principles are :
We can deliver one stop EPC (Engineering, Procurement & Construction) solutions to Clients.Our team is capable to work in different combination of responsibilities .
Construction Management Driven by a team of professional, PES has successfully executed so many projects in the past experience .
We provide services for designing & commissioning of old and new manufacturing facilities complying national and international cGMP guidelines.
We conduct third party GMP compliance audits of Pharmaceutical, Food Products, Medical Devices Manufacturing etc. industries on behalf of Indian & Overseas customers.
We provide technical guidance to design, prepare and implement Quality Management System of many industries as per US FDA, EU GMP, PIC/s, WHO, NSF & ISO Guidelines.
We provide guidance and conduct GAP analysis audit before final inspection/audit. US Food and Drug Administration,UK Medicines and Healthcare Products Regulatory Agency
We provide onsite trainings on Good manufacturing practices, Good documentations practices, Change Control, Good laboratory practices, Quality management system, change Control, Deviation, CAPA etc.
We provide guidance & prepare Qualification & Validation documents for Pharmaceutical, Food Products, Medical Devices Manufacturing facility, API manufacturing facility (Sterile & Non-Sterile) etc.
We provide regulatory services to Active Pharmaceutical Ingredients, Drug Products & Food Products manufacturing facilities for Active Pharmaceutical Ingredients, ompilation of DMF in CTD/eCTD format for US, Europe, Canada and ROW market .
We provide custom synthesis services through our national and global channel partners for Key Starting Materials and Intermediates, Active Pharmaceutical Ingredients and other activities .
We provide services in Pre formulation studies and many more formulation development activities.Pre formulation studies, Compatibility studies
We understand user needs and serve satisfaction to our clients. We act as an employee and help in preparation, implementation, and monitoring of QMS as per national and international regulatory standards in all aspects of Plant designing, commissioning, Qualifications, Validations, QMS Documentation, Education and Trainings on GMP.