+91 98290 98077
+1-519-498-5957
+1-603-203-0935
Satori Global HealthCare Product
Get StartedAbout us
Satori One Click Solutions is a Global Pharma & QA/QC Management, Legal and Regulatory Compliance Consultancy and Advisory Company rendering services to Pharma and other Healthcare product industries/sectors including Pharmaceuticals, API, Medical Devices, Cosmetics, Natural Health Products, Herbal Products, Nutraceuticals, Dietary Supplements, Food Products particularly for USFDA, Health Canada, CDSCO, EMA, MHRA, TGA, and other countries’ regulatory compliance matters.
It has been established with the aims & objectives of providing dedicated consultancy services round the clock, globally, across a varied range of service areas, in a cost effective and innovative manner keeping in view the specific needs and benefits of prospective clients through a team of committed professionals with a legacy of experience, knowledge, integrity and sound ethical practices.
Satori operates from offices in India, Canada, and the US, maintaining alliances with dedicated teams worldwide to meet clients' demand. The firm ensures high standards and quality of work by continuously monitoring and checking delegated tasks.
Satori offers complete outsourcing solutions, helping clients in various aspects of their operations, including identifying manufacturing sites, managing sourcing, ensuring GxP compliances, obtaining regulatory approvals, and conducting production site audits, QA-QC audits, facility audits, and more.
The company also provides consulting services that encompass Current Good Manufacturing Practices (cGMP), quality management, Good Laboratory Practice (GLP), validation, qualification, and regulatory agency documentation.
Satori specializes in USFDA, Health Canada, EU, CDSCO, EDQM, MHRA, TGA, and other countries' regulatory compliance matters, offering a comprehensive solution to clients in the Indian and international markets.
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Our Team
Satori One Click Solutions is a venture promoted and managed by technocrats, educationists and law professionals having a blend of over 60 years of combined experience in the field of pharmaceutical and other healthcare industry. The company is led by a diverse team of highly experienced and well-qualified professionals in the pharmaceutical industry, quality management, legal, regulatory compliances, and other relevant consulting areas.
Our core team commands an expert network of committed and prudently chosen professionals, enabling us to provide the same caliber of expertise of a specialist consulting firm but replicated across multiple disciplines and therapeutic areas.
Our team supports pharmaceutical and healthcare organizations of all sizes, including start-ups, established companies, investors, and academic institutions.
Composed of highly skilled and committed professionals with a legacy of experience, knowledge, integrity, and sound ethical practices, our team provides high-quality consultancy services to a wide range of clients across different sectors, taking care of their specific needs and thus helping their businesses succeed and achieve their full potential.
Prof. Dr. B.P. Nagori
Prof. Dr. B.P. Nagori (Co-founder) is from India having B. Pharm. (Hons.), M.B.A., M. Pharm., Ph.D., LL.B. degrees with a blend of around 42 years of experience in Manufacturing, Teaching, R & D, Administration and Consultancy areas.
Avinash K Arora
Avinash K Arora (Co-founder) is from Canada having B.Pharm., M.B.A., Cert. RAP Degrees with more than 20 years’ extensive experience in medical devices, pharmaceutical and health care industries and has held high level management positions in business development, regulatory affairs and scientific affairs.
PROF. Dr. Rakesh Gupta
Prof. Dr. Rakesh Gupta, B.Pharm (Hons.), M.S., Ph.D., former Professor & Principal at Lal Bahadur Shastri College of Pharmacy, Jaipur, India, has over 43 years professional experience in teaching, pharma production, quality assurance, administration. He has been a Member of Academic Council, Rajasthan University of Health Sciences, Jaipur; Member of Board of Studies (Pharmacy), Rajasthan University of Health Sciences, Jaipur and also Member, Quality Management Sub-committee, IDMA, Mumbai.
What are the problems the SatoriOCS is solving?
The pharmaceutical and healthcare sector, a highly knowledge-intensive field, poses challenges for new entrants who may lack the necessary knowledge to establish their ventures. Even existing companies, focused on routine production and marketing activities, often lack the time and expertise for legal and regulatory compliance.
In contrast to the manufacturing and marketing of consumer products, the pharmaceutical and healthcare industries are controlled, regulated and governed by Statutory Acts worldwide requiring licenses to manufacture, sale, distribute, import and export etc. and are also subject to strict compliance of laws. Pharmaceutical companies must secure approval for new products and maintain that approval for market presence.
Legal and Regulatory environment keep on changing and Pharmaceutical companies have to operate and interact with these dynamic environments. Keeping the pace for any company with such changing environment is a real challenge. The number of rules and regulations has significantly increased in the 21st century, placing a heightened emphasis on regulatory compliance management, especially within the pharmaceutical and healthcare sectors.
Regulatory compliance mandates vary by country, obliging multinational organizations to be cognizant of the compliance of regulatory requirements of each nation where they operate. Pharmaceutical companies must adjust their compliance practices to align with changing regulations and stringent laws, as errors and lapses are not permissible in products meant for humanity.
In response to the COVID-19 epidemic and the post-pandemic era, India has emerged as a global pharmaceutical hub, attracting new entrants and prompting existing companies to expand. Government of India is keen to move ahead and actively encouraging the establishment of more and more pharmaceutical and healthcare ventures, recognizing their vital role.
In India, the inclusion of Medical Devices in the Drugs and Cosmetic Act imposes compliance requirements on both existing and new medical device companies, necessitating the services of experts.
At global front also, the European Medical Device Directives (EU MDD) and Active Implantable Medical Device Directives are replaced by the European Medical Devices Regulation (EU MDR). The medical device producers have been given a transition period to adapt to these new regulations.
Our Achievements
How does SatoriOCS solve these problems
Being active in the industry, we are aware of its complexities and challenges. Leveraging our experience, deep domain knowledge, senior business expertise, and executive-level skill sets of the Indian and International pharma and healthcare industry and markets, we are equipped to provide the best possible solutions for our clients' problems while considering the legalities and compliances associated.
Satori consulting team provides precisely relevant support to prospective clients on various business issues. The designated team members, knowledgeable in requirements such as policies, procedures, and processes, work with prospective clients to understand their needs and customize solutions based on gap analysis. Our team believes in honest dealing of the project proposals.
At SatoriOCS, we are providing Pharma & Quality Management, Legal and Regulatory Compliance Consultancy and Advising services globally under one roof to Pharma and other Healthcare product industries, including Pharmaceuticals, API, Cosmetics, Herbal Products, Medical Devices, Nutraceuticals, Natural Health Products, Dietary Supplements, Food Products, Surgical Products, and Diagnostic Agents.
We understand that every business is different, and we take the time to get to know our clients and their businesses to provide the most effective solutions. We tailor our services to meet the specific needs of each client, working closely with them to provide the most effective solutions that will achieve the desired outcomes.
Building strong client relationships based on trust and mutual respect is fundamental to our approach. We work collaboratively with our clients, listening carefully to their needs and providing support and guidance throughout the process. At SatoriOCS, we take pride in our commitment to delivering exceptional service and achieving outstanding results.
Our Objectives
- To help businesses grow and profit through Pharma Management, QA/QC, Legal & Regulatory Affairs Compliance Consulting Services and Liaison Representation.
- To act as Global Pharma Management/ Pharma Regulatory Affairs/ Pharma Industry Consultants.
- To provide consultancy for manufacturing, marketing including online marketing, sales & distribution, trading, import & export of pharma products and related approvals from various global regulatory authorities including US FDA, WHO, and Drugs Controller General of India.
- To undertake analytical and research work of any kind for manufacturers, dealers and govt. departments.
- To provide consultancy/ networking/ liaising services among research seekers and research providers for commercialization of research.
- To assist with streamlining complex regulatory and legal requirements to speed the new products to the global marketplace.
- To help confirm that new products meet applicable regional, national, and international regulations.
Services
Our featured consultancy services include:
Pharma & Quality Management
- Good Manufacturing Practices (GMP) Compliance
- Good Laboratory Practice (GLP) Compliance
- Quality Management System (QMS) Development, Implementation, Improvement and Compliance
- Quality Assurance and Control
- Risk Assessment & Management Consultancy Services
- CAPA Management and Improvement
- Internal Audit/ Site Audit and Inspection Readiness/ Support
- Documentation Management
- SOPs, Dossiers, DMF
- Label Reviews
- Supplier Management and Audits
- Training and Development
Legal Compliance
- Trade Marks, Copyright and Patents
- US Agent Services
- Indian Agent Services
- Canadian Agent Services
- Pharma Litigation & Dispute Resolutions
- Environmental Law Consultancy Services
- Contracts and Agreements Consultancy Services
- Employment Law Consultancy Services
Global Regulatory Compliance
- US Regulatory Services [FDA (Food and Drug Administration)]
- Europe Regulatory Services [EMA (European Medicines Agency)]
- Canada Regulatory Services [Health Canada]
- Australia Regulatory Services [TGA (Therapeutic Goods Administration)]
- UK Regulatory Services [MHRA]
- India Regulatory Services [CDSCO]
- Regulatory Compliance of other Countries
- Meeting with NCs
- Labeling, Packaging and Advertising Compliance
- Clinical Trial (Design and Management) Compliance
- Pharmacovigilance Compliance
- Market Complaints/ Post-market Surveillance
- Import and Export Compliance
Industries/Sectors-We Serve
- Pharmaceuticals / OTC/ Generic Products/ Dental Products/ Veterinary Products
- API/ Drugs/ Intermediaries
- Cosmetics
- Herbal Products/ Extracts
- Medical Devices & IVD
- Nutraceuticals/ Designer Food Products/ Natural Health Products/ Dietary Supplements
- Food Products
50
Projects Completed
10
Current Projects
150
Submissions
70
Gap Assessments
Contact Us
INDIA Office
II, Nagori Tower,Inside Siwanchi Gate,
JODHPUR- 342001 Rajasthan, INDIA
Phone: +91- 98290 98077
CANADA Office
229 Deer Ridge DrKitchener, ON
N2P2K5
Phone: +1-519-498-5957
USA Office
3729 Shires Edge DriveNew Hill, North Carolina
USA
27562-9341
Phone: +1-603-203-0935
News & Articles
For updates and news stay tuned.
Career & Internship
Join Satori Team. For any queries regarding career and internship, write a mail to us at careers@satoriocs.com
Pro Bono Practice/CSR
Believing in its Corporate Social Responsibility (CSR), Satori is dedicated in providing pro-bono services and endeavors to serve the society in the best possible ways.
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