May 2025 | 7 • New drug approvals • Subsequent new drug approvals • Post-approval changes, if needed • Obtaining BE NOC Critical certifications and accreditations CliniExperts has earned these badges through sheer hard work and unwavering commitment to all-round excellence: ISO 9001 - For maintaining impeccable quality management systems (QMS) ISO 27001 - For hosting lean and robust information security management systems (ISMS) ISO 13485 - For consistently maintaining a world-class QMS for design, development, and production of medical devices. WHOLESALE 20B and 21B - For maintaining immaculate systems for procuring drug licenses in India. Final word I am positively biased towards CliniExperts for its meritocracybased market standing, supported by the trust of a rapidly growing roster of overseas clients. Go after CliniExperts! Contact: Dr. Ashwini Kumar Company: CliniExperts Services Pvt. Ltd. Website: https://cliniexperts.com/ • Form 20-B for wholesale license • Repacking permission under Rule 37 • Additionally, to sell their products in the Indian market, companies need a registration certificate under form 40, which guarantees that products conform to Indian regulatory standards. • And more. These two links to CliniExperts website provide detailed information. With its experience and proven capabilities, CliniExperts covers all the above registration/licensing mandates. CliniExperts’ services as Authorised Agent As I covered earlier, appointment of an Indian authorised agent is a blanket requirement for healthcare companies aspiring to be in the Indian market. It applies to the pharmaceutical drug category too. CliniExperts, as a reputed Indian drug wholesaler possessing Form 20B and 21B licenses, can provide you these standout services: • Full-spectrum compliance with the Indian laws and regulatory framework • Facilitate testing of drugs at central government laboratories and obtaining relevant clearances/permissions for their commercial use • Filing form40 application and subsequently procuring Form41 drug registration certificate • Issuing Form9 to exporters to facilitate drug imports to India • Provide prompt and effective assistance in case of adverse event reporting and product recalls, if and when necessary
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