Footprints and Clients

Our Footprints

. Credited with successful completion of over 100 Assignments meeting Client's Satisfaction in India and Abroad

. Led 27 regulatory audit approval of various companies manufacturing API, OSD, Sterile and Medical devices: USFDA, MHRA, ANVISA, WHO, PIC/S, TGA, MCC and ISO 13485.

. Collaborative support to @ WHO-Gates foundation-BCG initiatives for sourcing complex drugs for the poor across the Globe @ McKinsey-Cadila pharma initiatives for 'work in simplified eco-system leveraging automation (WISE)' program @ Bain and Co. Disruptive Operational Due-diligence in India and Abroad

. Instituted clients customised internal and supplier/ vendor quality audit programs and technology transfer models.

. Hand on exposure of meeting compliance for the mAbs, bone marrow stem-cells, tissue culture and r-protein manufacturing following GTP, GMP, ICH, EudraLex and CFR; intended for India, South Africa, EU, Brazil and US.

. Audited 250+ CRO, CTO, CMO, compounding pharmacy, Pre-clinical labs & animal house and medical devices in India and Abroad

. Successfully completed remediation of DI breaches and quality system of six organizations manufacturing Biopharma, API, OSD and Sterile and mitigated the business risk of import ban/ alert.

. Made assessment of effectiveness of over 1500 event investigations (root cause and impact analysis) of OOS, OOT, human errors & DI, NCR, deviation, incidents, etc. and to enhance Rubrics score holistically in the Biotech, Pharma and Devices manufacturing sites.

. Imparted 400+ hours of effective training and workshops on various GxP articles (QS & cGMP, aseptic practices, DI & Human errors, Effective Investigation & CAPA, b-GMP & Quality culture, etc.) in India, China, Bangladesh and Kenya.

. Accomplished process simplification and throughput enhancement of 5 companies manufacturing Biopharma, API, OSD and sterile products collaboratively.

. Supported 5 organizations manufacturing recombinants, OSD & sterile establishing lean management of quality & analytics and integrated data systems collaboratively.

. Completed 9 greenfield Projects of Monoclonal antibody & recombinant, API, BFS, Oncology OSD/sterile, BSL-2, Platform tech.

. Quality lead for the assessment of design concept, C&Q, and Validation following risk-based approach ASTM 2500E.

. Computer system validation for Standalone and integrated data systems (LIMS, EQMS, SAP, Empower, LabSolution, e-logs, e-BMR, DCS).

. Remote & Virtual support to Clients on digitalization & automation in QS, investigation, regulatory audit preparation, training, etc.