Our Team
Ensuring a smooth and effective submission process today goes beyond the old ways of eCTD publishing.
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Our aim is to be a leader in the areas of regulatory services and dossier compilation and also to provide value-added solutions to the customers we serve.
​More than 12 employees are working with us to make things in a swift manner. 100% eCTD technical Approval.
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Our team is committed to a high degree of ethical standards in our operations and the maintenance of strict confidentiality to protect your data and intellectual property. Speed is the essence of today’s competitive business environment, therefore we help get to the Market faster and on Time, by providing excellent and cost-effective regulatory services.
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Our Team
Gaurav Sindhu, CEO
Justine King, CFO
I have more than 14 years of global regulatory experience and leading teams in handling NDAs, ANDAs, and MAAs around the world, from initial submissions including health authority interactions to product approvals. Experience in Regulatory submission in eCTD filing USA, NPRA Malaysia, Brunei, EU, GCC, NAFDAC, CIS countries, etc.
Member of the senior management team playing a key role in the development of the company’s US operation (expansion of team from 4 to 50+). US Regulatory Liaison for several commercial products in the Anti-viral, Anti-infective and Pain Management therapeutic arena; including Celebrex, Lyrica, Vfend, Eraxis and Viracept
Maritza Pastoriza
Rajesh Nehra
info@regulatoryaffairs.in | Phone: +353 89 4544055
Regulatory Affairs - GCC, MDR, FDA, CER, 510k, RoHs, Reputable, bilingual, and reliable professional offering 18 years of quality experience.
A proven performer in delivering quality & regulatory while developing methods for process enhancements.
Expert Validation, Worked for UKMHRA, USFDA, TGA (Regeneron, Backman Coulter-PSC Biotech- Ireland, Julphar Gulf Pharmaceutical Industries-UAE, and also worked with Hospira Healthcare India Pvt. Ltd., (A Pfizer Company) and have total 11+ years’ professional experience in leading regulatory pharmaceutical.