Avinash K A.

Avinash K Arora, BSc Pharmacy, MBA, Certified RAP

Are you navigating the complexities of regulatory compliance for health products, cosmetics, medical devices, or food in North America? With over 23 years of hands-on experience and in-depth knowledge, I am here to assist you with all your regulatory needs. What I Offer: 🔹 US Agent Services I provide comprehensive representation for foreign manufacturers, ensuring all FDA and Health Canada requirements are met. 🔹 Label Compliance Whether you need assistance with FDA or Health Canada labeling standards, I will ensure your products meet all regulatory requirements. 🔹 Cosmetic Notification (Health Canada) & MOCRA (US FDA) I facilitate smooth and compliant registrations, ensuring timely approvals and reducing delays. 🔹 Medical Device Submissions (Health Canada) & 510(k) Submissions (US FDA) From premarket notification to licensing, I guide you through the complex regulatory pathways for your medical devices. 🔹 Food Establishment Registration (US and Canada) I manage the entire registration process for food establishments, ensuring compliance with US FDA and Health Canada. 🔹 DIN & NHP Submissions (Health Canada) I have extensive experience preparing and submitting Drug Identification Numbers (DINs) and Natural Health Product (NHP) applications. 🔹 Site Licensing & GMP Certification (Health Canada) I handle site license applications and provide GMP certification support for manufacturers, ensuring they meet all Health Canada standards. 🔹 SOP Review & Writing I review and draft Standard Operating Procedures (SOPs) tailored to your operational needs, ensuring regulatory compliance and efficiency. 🔹 MDSAP & ISO 13485:2016 Certification I assist companies in obtaining MDSAP and ISO 13485:2016 certifications, ensuring their medical devices meet international quality standards. 🔹 HACCP/Food Safety Plans & PCP Plans I develop and implement effective Hazard Analysis Critical Control Points (HACCP) and Preventive Control Plans (PCP) for food safety compliance. Urgent Compliance Needs? I specialize in handling urgent compliance matters, helping you avoid penalties and regulatory delays. Why Work With Me? With a BSc in Pharmacy, an MBA, and being a Certified Regulatory Affairs Professional (RAP), I have the knowledge and experience to navigate the strict regulatory environments of both the U.S. and Canada. My services ensure that your products meet all the necessary requirements to enter and remain in the market successfully. Let’s Get Started! Contact me today to discuss how I can help streamline your regulatory processes and get your products to market faster.