Bluemoon Consultancy And Services

Bluemoon Consultancy Services offering a technical consultation in the areas of Project, GXP, Regulatory, ISO, Quality Compliance, Validation and Qualification; to the Pharmaceutical, Biopharmaceutical, API & Allied Health and chemical industries. We have experience of Formulation, API, Vaccine, Chemical and IT industries. We worked with international consultants and clients. We have working experience with sterile and non sterile facilities; human and veterinary medicines. GlaxoSmithKline Nasik and GSK Bio Belgium are few of our reputed clients. We have pharmaceutical, Biopharma (vaccines), API, Packaging Industries Manufacturers and Suppliers as our clients. o Process equipments, Testing Instruments, Packing equipments; Gap Analysis, Risk Analysis; CAPA, CLIA, SLIA, Risk Register; Process Validation, Method Validation; Aseptic Operations; Computerised System Validation, SCADA Validation; Cold Chain Validation; Shipment Validation; Betalactum contamination Validation; Aseptic Equipment Maintenance; Boilers, chillers, heat exchangers, cold rooms, DG validation, Reactors, filters, rotavapours, lyophilizers validation; EM Validation; Tabs/ Capsule Machines; AAT,ACS,BMS, Steriliaers, LAF, Cold chain How BCS can support? o New & revamping Project support o Act as QA – QC in absence of competent staff; Approve QC /QA documents & issue COAs o Face FDA Audits/ Vendor Audits on behalf of client, Prepare Audit Reply o Audit Preparation and Conduct Internal Audits o Training of Staff on various topics as per client requirement o Prepare Validation protocol, Review validation documents and Write validation Report o Provide Validation Template o Give Analytical Solutions; Technological Solutions o Act as GMP, Validation & project Consultant for site