RegAgile is independent regulatory consultancy services and solution provider for life sciences industry based in Singapore since April 2022. Today RegAgile works with strong network of regulatory experts across the world (Europe, Australia, India, MENA, and SEA) and clients globally from MNCs to SMEs.
With over 18 years of experience in the field of Regulatory Affairs and compliance, we offer subject matter expert guidance and consultation right from the product development stage ensuring the robust regulatory strategies to smooth submissions that meet the global & local regulatory requirements and are compliant.
Our network of local experts is fully equipped to enable successful registrations, communication with local health authorities ensuring the support at every stage during the registrations.
Our expertise qualifies us as a strong regulatory partner. We provide the following services and solutions for Pharma and Consumer Healthcare
Area of Expertise: Consumer healthcare (OTCs, Health Supplements, Nutraceuticals, Food Supplements, Dietary Supplements, Natural products) Pharma ( Generics and NCEs, Rx or OTC, Rx to OTC Switch), Clinical, Medical Devices, Cosmetics ( Personal care, feminine care, Beauty products), Food and Beverages,Nutrition products- (Infants, mothers, and adults)
Regulatory advisory services:Regulatory Market Intelligence,Technical Scientific Due diligence, Regulatory Strategy, Registration & Marketing Authorisations, Lifecycle Management, Clinical Regulatory Services
Regulatory Solutions : Project management, Feasibility assessment, Gap analysis, Due diligence, eCTD/CTD Dossier writing, Technical writing- Module 2.3 and 3, Medical writing- M2.4, 2.5, 2.6, 2.7, 4 and 5, Marketing Authorisations,Product assessment, Claim assessment.
The strength of RegAgile lies in our collaborative approach to problem solving.
RegAgile also works closely with strategic partners to provide end to end clinical solutions to our clients
Company Details
Founded
-
Address
Block 109, The Palette, 14-22,, Pasir Ris Grove,singapore
Industry
Business Consulting And Services
NAICS
Management, Scientific, and Technical Consulting Services
Management Consulting Services
Other Scientific and Technical Consulting Services
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