Brijesh Parlekar's Colleagues at ProRegulatory Biosciences Ltd.
Brijesh Parlekar's Contact Details
Saskatoon,Saskatchewan,Canada
ProRegulatory Biosciences Ltd.
Brijesh Parlekar's Company Details
ProRegulatory Biosciences Ltd. is a federally incorporated biotech regulatory affairs consulting company in Canada. The company name was created with the help of our regulatory affairs experts, who are Pro in their regulatory affairs expertise (ProRegulatory) and focus mainly on biosimilar/biologics (Biosciences). Hence, ProRegulatory Biosciences.ServicesClone to commercialization biosimilar/biologics regulatory affairs support.US FDA meeting briefing packages, EMA scientific advice, IND, CTA, IMPD, MAA, BLA preparation, and product life cycle management for US FDA, EMA, Canada, and the Rest of the World.ANDA dossier preparation for US FDA.The team has hands-on experience in preparing IND, IMPD, Interact meeting packages, EMA scientific advice, US FDA biosimilar meeting briefing packages, BLA for the USA, and MAA for EMA, and various regulatory applications for global regulated markets.