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Global Regulatory Services

Welcome to the Satori OCS Global Regulatory Services, where we lead you through the intricate world of international regulatory compliance. As a renowned player in the regulatory field, we specialize in offering comprehensive services for Pharmaceuticals, Drug Licenses, Medical Devices, In-Vitro Diagnostics (IVG), Cosmetics, Natural Health Products (NHP), and Food Licenses across multiple countries. Our extensive expertise helps you ensure that your products meet the stringent standards and regulations of various key countries, including the US, India, UK, Europe, Australia, and Canada.

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Navigating Global Regulatory Services

Global regulatory services refer to specialized consulting and advisory services offered by firms to help businesses and organizations navigate the complex landscape of international regulations, compliance requirements, and standards. These services are designed to assist companies in various industries to understand, implement, and maintain regulatory compliance across multiple jurisdictions. Businesses, particularly those operating internationally or in highly regulated industries, often seek the expertise of regulatory service providers to avoid legal issues, reputational damage, and financial penalties resulting from non-compliance. These services offer a comprehensive approach to managing regulatory challenges and maintaining ethical business practices across diverse markets.


Our Comprehensive Global Regulatory Services

Pharmaceuticals and Drug License Assistance

  1. We facilitate the Drug License application process across different countries, helping you ensure your pharmaceutical products meet local regulatory requirements.
  2. Our support ranges from documentation preparation to compliance checks, simplifying your path to international pharmaceutical markets.

Medical Devices and IVD Compliance

  1. We guide you through the intricate process of gaining regulatory approval for Medical Devices and In-Vitro Diagnostics across diverse international markets.
  2. Our experts help you ensure your products adhere to the specific standards set by regulatory bodies in each country.

NHP Regulatory Services

  1. Our team navigates the complex web of Natural Health Product regulations, helping you ensure your products comply with varying guidelines in different countries.
  2. From ingredient assessments to labeling compliance, we help you ensure your NHPs meet the regulatory benchmarks.

Cosmetic and Food License Compliance

  1. Navigating the world of Cosmetic and Food License regulations demands precision. We assist you in gaining regulatory clearance for your cosmetics and food products in different countries.
  2. Our guidance spans from ingredient assessments to labeling and packaging compliance.



Countries We Cover


US FDA Regulatory Services

Our experts streamline the process of gaining regulatory approval for your products in the US, including FDA compliance.

We ensure your products meet the stringent requirements set by US regulatory bodies.

India CDSCO Regulatory Services

With our in-depth understanding of the Indian regulatory landscape, we guide you through the complex processes of gaining licenses and approvals in India.

Our services help you ensure that your products comply with CDSCO regulations across various sectors.

United Kingdom MHRA Regulatory Services

We facilitate the process of gaining regulatory approval for your products in the UK, adhering to the standards set by UK regulatory authorities.

From NHPs to Medical Devices, we help you ensure your products meet UK compliance requirements.

European Union EMA Regulatory Services

Navigating the regulatory requirements of the EU demands expertise. Our team assists you in gaining CE Marking and meeting other EU regulations.

We help you ensure your products adhere to the rigorous standards set by EU regulatory bodies.

Australia TGA Regulatory Services

Our experts guide you through the regulatory processes in Australia, including TGA compliance.

We ensure that your products align with Australian regulatory guidelines.

Health Canada Regulatory Services

Navigating Health Canada's regulations requires precision. We facilitate the process of gaining regulatory approval for your products in Canada.

Our services cover various sectors, helping your ensure your products meet Canadian compliance benchmarks.



Why Choose Satori OCS Global Regulatory Services


  1. Expertise across Multiple Markets

    Our experienced team brings in-depth knowledge of regulatory landscapes in key markets, helping you ensure timely compliance.

  1. Customized Solutions

    We tailor our services to the unique requirements of each country and industry, guaranteeing a precise fit for your products.

  1. Seamless Navigation

    With Satori OCS, you can navigate international regulatory complexities with confidence, leaving no room for compliance gaps.

  1. Efficiency and Success

    Our services expedite your global market entry, helping you ensure regulatory compliance without unnecessary delays.

Select Satori OCS Select Satori OCS to assist you in reaching international regulatory compliance. Get in touch with us right away to explore how our knowledge can make navigating the regulatory minefields of several nations easier for you.


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FAQs

Q1. Why you shall select Satori OCS for outsourcing regulatory services?

Selecting Satori OCS for outsourcing regulatory services is a smart choice. Satori OCS excels in preparing various regulatory documents for pharmaceutical products, including ACTD, CTD, eCTD, US DMF Types II to V, Canadian DMF, and conducting cGMP audits and vendor audits. Our track record speaks for itself. Contact us with your details for more information
● Full Name and Designation
● Company Name and Address
● Email ID
● Phone Number
We are dedicated to help your regulatory needs are met with expertise and precision.

Q2. Why customers always prefer to stay with SATORI OCS?

Customers wish to remain with Satori OCS because of :
● Quality service at a reasonable cost
● Timely delivery
● Courteous and helpful support
● Strict confidentiality


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