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Rajendra Vidwans

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After working as employee for 34 years in best Pharma companies, started consultation and Consulted about 65 companies in last 12 years of consultancy in the field of sterile and non sterile dosage forms, formulations and API both. Last 7 months did Third party review of 10 sterile lines after client's FDA audit and submitted detailed review and currently doing another third party review of another company for remediation program. We also help in upgrading existing facilities and person's training in GMP requirements. We are more prepared and glad to help pharma companies for all international audits.. We are able to fill that wide gap between Regulatory requirements and inspector's expectations which are causing problems to companies now. While QA department of the company focus on requirements only, we also add on what auditors are expecting much more than requirements. We undertake due diligence of plants/facilities for potential, for products, machinery, capabilities, people etc. We undertake third party audits on behalf of procurement companies of USA and Europe. I am effectively using 45 years experience in Pharma operations including production, projects, Quality, now working independently in GMP audits, inspections, training, GMP consultations, Quality systems, Risk assessments etc. Those companies which are going to face US FDA, MHRA, TGA, WHO Geneva audit soon; may approach us for pre-audit and assess their Quality/GMP status or those who have problem with these audits in recent past also should approach us for correction and re-approval as soon as possible with our help! We can help in both scenarios. I have experience in putting up and operationalising all sterile formulations projects and production, for last 36 years culminating in US FDA approval for a facility. pl Contact: +91 9850894074 Email: [email protected], [email protected]

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