What We Do
We believe in mutual growth
Rely On Our Experts For Regulatory Matters
Being active in the industry from the past two decades, we are aware of its complexities and challenges. We assist you to find the best possible solution for your problem keeping in mind the legalities and compliance associated.
Arora 297 consultancy specializes in US FDA, Health Canada, EU and other countries regulatory compliance matters. We provide best-in-industry consultancy and assistance to firms dealing in the medical device, drug, cosmetics, diagnostic kits, biologics and food for compliance with US & Canada regulations and guidelines.
Global Regulatory Services
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01Strategy Planning
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02PRE Submission
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03Submission/Registration
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04Post Submission/Approval
We offer the following solutions
Featured Services
We have 20 years of Experienced in Trusted Regulatory Services
REGULATORY
From ingredient compliance checks, label compliance, regulatory submissions, life cycle management of NHP, drugs, cosmetics and medical devices, and all complimentary services around the product.
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STRATEGIC ADVICE
From strategic product development, formulation support, gap analysis, market research report, and data analysis.
COMPLIANCE AND QUALITY
Establishment License, Site License, Import/Export, eCTD, CTA, DMF, Publishing, GMP, GLP guidelines, SOP development and more
POST APPROVAL
Post Marketing Surveillance programs, Risk Management Plan, Pharmacovigilance reporting and support
EDUCATION, TRAINING & CONSULTING SERVICES
Training services to individuals, organizations and institutions in person and via electronic medium; to enable a practical understanding of the Global regulatory process and updates. We offer both custom and standard training sessions. Learn more about some of the education modules by checking our Knowledge page.
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