Expert Regulatory and Compliance Consultants

Compliance Solutions for

HEALTH CANADA & FDA NHP

NPN, Nutritional Supplements, Medical Devices, OTC Medicines, Cosmetics, and Food.

More than 10000 NHP Registered Successfully

NHP Licensing & Compliance Solutions

Medical device Registration

Medical Device License Experts Canada (MDEL & MDL) & USA (510(k) Medical Device Registration)

Medical License label compliance solutions for Class I, II, III, IV,Medical Device Establishment License and Renewals, Software Medical Device (SaMD)

Get in touch with us to

Hire a US FDA Agent

We offer the following solutions

TRUSTED REGULATORY & SCIENTIFIC AFFAIRS SERVICES

Medical Device

We are providing full services for EUA/510(k) submissions, MDEL - Health Canada, IO/MDL submissions, Classification of Devices, IVDD and Labeling compliance

U.S. Agent & Legal Representation in Canada

At fraction of cost we can represent your company in the U.S.A and Canada. We have made it easy for you. Drop us an email or call us

Natural Health Products (NHP) Canada

We provide full end to end NHP Product approval services, Site License, SOPs, GMP Audits, Formulation Assistance, Label Compliance. Over 90% success rate with >500 successfull submissions. Free Gap analysis report will be provided on request

Disinfectants

We are providing full end to end services with DIN submissions in Canada, EPA submissions in the USA and OTC SPL submissions FDA - Call us today for any questions related to Hand Sanitizers, Disninfectant spray, Disinfectant wipes

Cosmetics USA | Health Canada | Europe

We provide full assistance with ingredient compliance, notifications, registrations, claims, and labelling. Are your cosmetic ingredients acceptable by Health Canada standards? Have you checked for VOC and California Prop 65? Have you checked for allergens ingredient (fragrance) for EU?

PPE - COVID-19

We are providing full assistance services in preparing submissions, label compliance and regsitration of masks, surgical masks,Isolation Gowns, Surgical Gowns with Health Canada and US FDA

Food

We support with Label Compliance, prepare Nutrition Facts table, Ingredient & allergen checks, Notifications to health authorities, registration of facilities (Foreign and Domestic), Import & Export issues, Novel food submissions, New ingredient submissions and more

Regulatory Intelligence & Updates

All new regulatory updates, changes, notifications, new policies

We believe in mutual growth

UNPARALLELED CONSULTING & REGULATORY SERVICES

Arora 297 consultancy specializes in US FDA, Health Canada, UK, EU and Australia regulatory compliance matters. 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)

> SKUsCosmetic ingredient and label compliance
> Happy Clients
NHP > NHPs Product License

More than20years of industry experience

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 ever changing regulatory requirements.

The road to becoming a global company looks difficult to navigate. We will make it easier for you!

We at Arora 297 Consultancy, lend you with a helping hand to get things going for you in the US and Canadian market. Our experienced team of consultants, lead by Avinash K Arora, is knowledgeable and abreast with present-day trends to comply with firms with applicable laws and regulations. From regulatory submissions to strategy development, from management to compliance, from communications to labelling, we handle it all so that you can focus on your business and grow it by leaps and bounds without any regulatory hassle.

Regulatory Strategy

We, at Arora 297 Consultancy, look to grow our business associations into long-term relationships. We assist you to plan, strategize and execute strategies that are designed by skilled professionals who maintain a connection with you at all times, starting from assessments, registration, trials, licensing and quality assurance for fruitful outcomes.

Pre-registration

For seamless and hassle-free execution, we offer pre-registration services like data generation, regulatory and compliance with a gap analysis. While the data generation and review is done in accordance with formulations and ingredients checks, the expert reports help in facilitating successful registration.

Registration

For carrying out successful registration, we provide services like Dossier review and submission along with technical documentation and administrative documents. Additionally, we also take care of dossier registration and submission to different authorities and query response management.

Post Approval

We try to be in touch with our clients for post-approval changes helping them to upgrade products with additional data as per country norms. We provide regulatory intelligence support in addition to planning, preparing and submitting fresh documents to the authorities.

GLOBAL REGULATORY SERVICES

Entering into the vast realm of medical and healthcare products in international markets of Canada, UK, EU, USA and Australia, requires a comprehensive understanding of complicated regulatory requirements.

01

Strategy Planning
02

Pre Submission
03

Submission/Registration
04

Post Submission/Approval

Regulatory Submissions

NHPs, DIN, Medical Devices, EPA, Food, New Dietary Ingredients, Cosmetics

Quality and Compliances

GMP, Quality Management System, Site License, Audits

Markets

U.S.A, Europe, UK, Canada, Australia, NZ, etc

Very happy to have found Avinash when we did. When I found him, we were in a bind and needed a lot of applications to be submitted to Health Canada. As we got started, I was impressed with his professionalism when he asked me, the client, to create an NDA.
NHP Submissions 20 + Products Botanic Research USA
Great experience with Arora 297 Consultancy. Very helpful, knowledgeable, professional and affordable. Look forward to working with Avinash again very soon!
Review 8 x Amazon product listings for problematic marketing claims
Excellent, will work with again. Prompt delivery, knowledgeable, and was willing to speak by phone to answer questions. Will be in touch again soon.
Review FDA Ingredient Submission