Arora 297 Consultancy – Navigating Regulatory Complexities with Expertise in Canada and the USA

Arora 297 Consultancy, a distinguished regulatory consulting firm, stands as a reliable guide for businesses operating in the medical device, Natural Health Product (NHP), food, cosmetic, and pharmaceutical sectors. Their team of seasoned regulatory affairs professionals possesses an in-depth comprehension of the intricate regulatory frameworks in Canada and the USA. Committed to assisting clients with confidence, Arora 297 Consultancy offers expert support to navigate the regulatory process seamlessly.

Q. Why Arora 297 Consultancy?

Expert Regulatory Guidance: Arora 297 Consultancy's team, comprised of experienced regulatory affairs professionals, brings forth a wealth of knowledge in the complex regulatory landscape of Canada and the USA. With a focus on medical devices, NHPs, food, cosmetics, and pharmaceutical products, they offer expert guidance to businesses seeking regulatory compliance.

Navigating Canadian Regulations: Specializing in Natural Health Product (NHP) License, the consultancy aids clients in acquiring the necessary approvals for their products in Canada. From NHP registration to obtaining NPN numbers, Arora 297 Consultancy facilitates a smooth process, ensuring compliance with Canadian regulations.

Streamlining Medical Device Registration: For businesses involved in the medical device industry, Arora 297 Consultancy offers comprehensive support for the registration process in Canada. Leveraging their expertise, they guide clients through the intricacies of medical device registration, ensuring adherence to regulatory standards.

Cosmetic Compliance Solutions: In the realm of cosmetics, Arora 297 Consultancy provides tailored compliance solutions for businesses in Canada. By offering guidance on label compliance and other regulatory aspects, they assist clients in meeting the necessary requirements in the Canadian market.

FDA Registration and US FDA Agent Services: Arora 297 Consultancy extends its expertise to businesses aiming for FDA registration in the United States. Serving as a reliable US FDA agent, the consultancy supports clients in navigating the regulatory landscape south of the border.

Commitment to Client Success: With a commitment to client success, Arora 297 Consultancy strives to make the regulatory process more accessible. Their dedication to providing solutions across various product categories underscores their role as a trusted partner in regulatory compliance.

Natural Health Products (NHP) Licensing Regulations & Solutions

Arora 297 Consultancy stands as a trusted advisor, specializing in assisting businesses in the natural health product (NHP) industry to navigate the intricate regulatory landscape set by Health Canada. Understanding the pivotal role NHPs play in holistic wellness, the consultancy provides comprehensive solutions to ensure compliance with the Natural Health Products Regulations.

Expert Guidance: Arora 297 Consultancy's team of experts possesses in-depth knowledge of the Natural Health Products Regulations. They offer specialized guidance on crucial aspects such as product licensing, site licensing, and product classification, providing businesses with the necessary insights to meet Health Canada's regulatory requirements.

Tailored Solutions for the NHP Industry: Recognizing the unique challenges faced by companies in the NHP sector, Arora 297 Consultancy delivers tailored solutions. Whether you are a manufacturer, distributor, or importer of natural health products, the consultancy offers personalized strategies to streamline your regulatory journey.

Comprehensive Services: Arora 297 Consultancy provides a range of consultancy services designed to support businesses at every step. From understanding regulatory requirements to obtaining approvals and licenses, their comprehensive approach ensures a smooth and confident market entry for your natural health products.

Trusted Partner for Compliance: Businesses can trust Arora 297 Consultancy to be a reliable partner in achieving compliance with Health Canada's regulations. The consultancy's expertise and knowledge empower clients to navigate the complexities of NHP licensing, fostering confidence in bringing their products to the Canadian market.

Medical Device Registration and Classification

Arora Consultancy emerges as a dependable consulting partner for businesses seeking compliance with Health Canada's Medical Device Regulations. With a focus on Medical Device Licensing (MDL), Medical Device Establishment Licensing (MDEL), and Software as a Medical Device (SaMD), the consultancy provides expert guidance on Canada medical device classification.

Expert Insights from Former Health Canada Specialists: Ensuring the quality, efficacy, and safety of medical devices is paramount. Arora Consultancy offers the expertise of former Health Canada specialists, providing valuable insights to navigate the intricacies of medical device compliance. Businesses can rely on this experienced guidance to meet Health Canada's stringent rules.

In Vitro Diagnostic (IVD) Medical Device License Support: Arora Consultancy specializes in assisting businesses in obtaining In Vitro Diagnostic (IVD) Medical Device Licenses from Health Canada. Additionally, the consultancy extends its support to facilitate 510(k) submissions for IVD devices in the United States, ensuring a comprehensive approach to global regulatory compliance.

Quick and Efficient Device Registration: Understanding the urgency in device registration, Arora Consultancy expedites the process, ensuring swift and efficient registration of medical devices in Canada. The consultancy's comprehensive approach covers the nuances of Medical Device Regulations, ensuring businesses meet all the necessary requirements for registration, sales, and commercial importation.

Stay Informed About Regulatory Updates: Arora Consultancy keeps clients informed about the latest developments in Medical Device Regulations. The consultancy provides insights into additional requirements for medical device registration and commercialization in Canada, offering a proactive approach to compliance.

Avinash K Arora | President & CEO

Avinash K Arora [BSc. Pharm, MBA, Cert. RAP] has more than 20 years’ extensive experience in pharmaceutical and health care industries and has held high level management positions in business development, regulatory affairs, scientific affairs and compliance with global companies that produce Pharma, Food, Cosmetic and NHP products.

Avii leads the Arora 297 Consultancy team in Canada, US & India presently. Avii provides strategic guidance to all types of regulatory submissions including: Cosmetic, Food, NHP, OTC, Medical Device and Generic Pharma. Proven champion in leading all projects from start to finish and has excellent ability to provide results based on interpretation of law, regulations and guidelines that directly benefit the business and clients.

Professional skills include, project management, regulatory strategy, product development, scientific writing, Health Canada & CFIA communications, FDA communications, formulation reviews, labeling reviews, Gap Analysis and much more.

“We provide best-in-industry consultancy and assistance to businesses dealing in the medical devices, drugs, cosmetics, diagnostic kits, PPEs and food and Nutraceuticals (NHPs).”