Aseptic / Sterile Manufacture
GCA has vast experience to manufacturing Aseptic Products according to US FDA, EMA & WHO guidelines and can easily support customers to manufacturing high quality injectable.
GCA has exclusive agreements with World Leading Biotech Centres in the Europe to ensure timely & cost effective Technology Transfer for Biotech Products.
GCA expert team can help to optimize manufacturing operations for Solid/Liquid/Cream facility.
Production of APIs
GCA provides GMP Compliance Services to APIs Manufacturer as per ICH Q7.
GCA ensure client has effective and robust Quality Assurance that facilitates GMP Culture and success of stringent inspection.
GCA provides services to ensure compliance of Good Laboratory Practices.
eCTD/CTD/NeeS Registration Dossiers
GCA provides full support to build right time dossier to ensure fast track registration in CTD/eCTD format.
Engineering (Water systems, HVAC systems)
GCA provides guidance & training for the Compliance of Good Engineering Practices.
GCA provides formulation support for all dosage forms and training to prepare effective Pharmaceutical Development Report.
Calibration & Validation
GCA provides training and onsite execution of Calibration/Validation as per GMP requirements.
Development of SOPs
GCA provides training and templates for all type of SOPs as per GMP/GLP/GxP requirements.
GCA provides onsite& offsite training programs and conferences by inviting leading speakers from Europe & USA.
Supplier Identification & Qualification
GCA provides support for sourcing of high quality material that ease the dossier development & registration process in addition to product stability.
GCA provides information technology solution to automat Quality System, QC Lab Operations, Manufacturing Operations & Warehouse Management System.
Corporate Image Enhancement
GCA provides multiple solutions to improve the Corporate Image of organization at national & international level.
GCA provides licensing in/licensing out solutions according to need of Pharma/Biopharma industry.
Operational Excellence & Optimization
GCA provides road map to control waste and optimize operations through compliance of Operational Excellence.
GCA provide solutions for export related markets Asia, CIS, Africa, Europe, South America & North America.
GCA provides the best ideas for fully GMP Compliant layout for new & existing facility keeping in mind latest GMP requirements.
GCA provide proposal to upgrade existing facility to meet current GMP Challenges.
GCA provides solution to meet Good Storage Practices (GSP) requirements, temperature mapping and flow of materials.
GCA provides solutions for the Certification of ISO 9001, 14001, 18001