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Pharma and other Healthcare Products Licence and Quality Management Consultancy
Welcome to Satori OCS, your reliable partner for Pharma & other Healthcare Product Licence and Quality Management Consultancy services. To ensure smooth and legal operations, we offer complete and customized solutions to Pharmaceuticals, Cosmetics, Medical Devices, IVD Devices, Natural Health Products (NHPs), Veterinary Medicine, Active Pharmaceutical Ingredients (API) and other Healthcare product ventures engaged in manufacturing, sales & distribution and import of these products. Our skilled team of professionals is dedicated to assisting you with every step of setup and optimizing your quality management including quality assurance and quality control operations. We are conversant about the complexity of the pharmaceutical and other healthcare product sectors.
Under Pharma & other Healthcare Product Licence & Quality Management Consultancy, we provide services inclusive of:
Manufacturing, Sales and Import Licenses for
- Allopathic Drugs (Modern Medicine), Homoeopathic Medicines, Ayurvedic Medicines
- Cosmetics
- Medical Devices and IVDs
- Natural Health Products (NHPs)
- Veterinary Medicines
- Active Pharmaceutical Ingredients (APIs)
Approval of Commercial Testing Laboratory for Testing and Analysis of Drugs and Cosmetics
Monitoring and Guidance for
- Good Manufacturing Practices (GMP) Certificate
- Good Laboratory Practices (GLP) Certificate
- Market Standing (MS) Certificate
- Non-Conviction (NC) Certificate
- Certificate of Pharmaceutical Products (COPP)
- Free Sale Certificate
- WHO GMP Certificate etc.
Establishment of Units/Sections
Research & Development/ Trouble Shooting
Clinical Trials
Pharmacovigilance
Label Reviews
Market Complaints/Post Market Surveillance
Quality Management Services (QMS)
What we do
Understanding Your Vision
At Satori OCS, we begin by understanding your specific objectives for running your pharmaceutical company. To fully understand your needs, target markets, and long-term goals, we hold in-depth discussions.
Regulatory Compliance
Navigating the pharmaceutical industry's regulatory framework can be difficult. Our devoted team aids you in understanding and complying with the regulations, permissions, and licenses essential for the establishment of your pharmaceutical firm.
Infrastructure Planning
Careful design of the infrastructure is necessary for a productive pharmaceutical company setting. We work together with you to design the best facility plan, considering your demands for distribution, storage, and manufacturing.
Technology and Equipment Selection
The selection of the appropriate technology and equipment is essential for a successful pharmaceutical setup. To ensure effectiveness and conformity to industry standards, our experts offer advice on choosing suitable equipment and technology.
Project Management
Satori OCS manages the entire setup project, relieving you of the responsibility. We help smooth and fast execution from procurement through construction, keeping you updated along the way.
Registration Process of Pharma Manufacturing Plant in India
To ensure compliance with pharmaceutical regulations, the registration procedure for Pharma Manufacturing Plant in India includes several steps and compliances. An overview of the registration procedure for establishing a pharmaceutical manufacturing facility in India is described below:
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Business Registration
Register your pharmaceutical company as a business and as a legal person, such as a Limited Liability Partnership (LLP), a Private Limited Company, or a Proprietorship / Partnership Firm. Obtain the certifications and permits required by the chosen business structure.
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Industrial Licensing
Obtain a pharmaceutical manufacturing licence from the State Drug Control Authorities or the Central Drugs Standard Control Organization (CDSCO). The type of pharmaceuticals you plan to manufacture will determine whether you need a license from State or Central Drug Control Authorities.
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Land and Location
Obtain the necessary property and infrastructure for establishing the manufacturing facility. The area should adhere to zoning laws and fulfill all necessary environmental and safety standards.
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Qualified Person (QP)
Appoint a Qualified Person (QP) who holds the appropriate education and expertise in accordance with Schedule D of the Drugs and Cosmetics Rules, 1945. Compliance with other laws and good manufacturing practices (GMP) is QP’s responsibility.
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Building and Facility Compliance
The production facility should be designed in accordance with the Drugs and Cosmetics Act and Rules, as well as any connected facilities. The design should follow GMP specifications for producing pharmaceuticals.
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Equipment and Machinery
Obtain the equipment and machinery needed for producing pharmaceuticals. Ensure that the selected equipment and machinery produce pharmaceutical items which satisfy the required quality requirements.
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Formulation Approval
Submit the details of the formulations you intend to manufacture to the CDSCO or State Drug Control Authorities for approval.
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Environmental Clearance
Obtain environmental clearance from the appropriate authorities to guarantee that environmental standards are being followed.
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Infrastructure and Safety Certifications
To ensure compliance with quality and safety standards, obtain the relevant certificates, such as ISO (International Organization for Standardization) and other safety certifications.
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Testing Laboratory
To execute quality control tests on raw materials and finished pharmaceutical products, set up an internal testing laboratory or build a partnership with an approved testing laboratory.
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Premises Inspection
To ensure that the premises are in accordance with pharmaceutical standards, the State/ Central Drug Control Authorities' Officer will inspect them.
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Grant of Manufacturing License
The State/ Central Drug Control Authorities will grant you a manufacturing license allowing you to begin producing medicines after a successful inspection and completion of all requirements.
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Regular Compliance and Renewal
After acquiring a manufacturing license, it is crucial to comply with all ongoing obligations, including regular inspections.
The registration process for pharmaceutical manufacturing plant in India can be complex and time-consuming. To ensure a simple and lawful registration process, it is advised to get legal counsel and support from professionals knowledgeable about pharmaceutical rules.
Quality Management including QA/QC Operations
Quality management is the act of overseeing all activities and tasks needed to maintain a desired level of excellence, ensuring that an organization, product, or service consistently functions well. It focuses on product/service quality and the means to achieve it. A quality management system (QMS) formalizes processes, procedures, and responsibilities for achieving quality policies and objectives. It coordinates and directs activities to meet customer and regulatory requirements, improving effectiveness and efficiency continuously.
A robust QMS is a fundamental requirement for medical device registration and regulatory compliance, establishing standardized processes, procedures, and controls for quality, safety, and efficacy. It encompasses design controls, risk management, document management, and post-market surveillance.
The three key components of QMS are Quality Control (QC), Quality Assurance (QA), and Quality Improvement (QI). QA focuses on preventing mistakes and defects, while QC focuses on identifying and correcting them, ensuring the quality of products or services. QI involves systematic actions for measurable improvement.
In pharmaceutical manufacturing, QA/QC management is crucial for producing high-quality, safe, and effective medicines. It uses methodical techniques to uphold conformity with legal requirements and industry standards, including quality systems, inspections, audits, process validation, and testing raw materials and finished goods. Focusing on continuous improvement, adherence to quality standards, and risk mitigation earns trust from patients and regulatory authorities.
Implementing a robust QMS involves the following activities
The pharmaceutical industry is built on quality. To comply with legal obligations and uphold the highest standards, our consultants assist businesses in creating and implementing QMS.
To simplify processes and guarantee consistency, effective SOPs are crucial. Our staff helps you create thorough SOPs that address every facet of your pharmaceutical business, from manufacturing to distribution.
Maintaining product quality and patient safety depends on identifying and mitigating possible risks. Satori OCS carries out extensive risk analyses and aids in the implementation of risk mitigation measures.
Quality assurance requires a team that is well-trained. We provide specialized training courses to improve your staff's abilities and give them the tools they need to perform their jobs well.
To make sure that quality standards are being followed, regular internal audits and compliance checks are required. To find opportunities for improvement and compliance gaps, our professionals conduct audits and evaluations.
Why Choose Satori OCS for Pharma & other Healthcare Product Plant Setup & Quality Management Consultancy
Our team is made up of seasoned experts with years of pharmaceutical industry expertise. We produce results that surpass expectations by having a thorough awareness of industry best practices and regulatory frameworks.
We think that no two people are the same. Our solutions are meticulously designed to meet your individual requirements, ensuring that your pharmaceutical setup and QA/QC management properly correspond with your corporate goals.
Satori OCS provides end-to-end support for the entire procedure, from the initial consultation to the final implementation. We are committed to your success as your devoted partners.
Our history speaks for itself. We have gained the trust of clients across the country by completing multiple successful QA/QC management projects and setups for the pharmaceutical industry.
At our company, customer satisfaction comes first. We place a high value on open communication and work closely with you to provide solutions that successfully meet business challenges and possibilities.
We take satisfaction in being your trustworthy partner at Satori OCS for Quality Management including QA/QC Operations and Pharma and other Healthcare product Plant Setup Consultancy. With our in-depth expertise, extensive experience, and dedication to perfection, we are committed to assisting you in establishing a prosperous pharmaceutical and other healthcare business while upholding the highest standards of quality. Let's set off on this road to accomplish your pharmaceutical objectives together. Get in touch with us right now to discuss how we can support your success in the thriving pharmaceutical and healthcare sector.
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FAQs
Q1. How to start a pharma company in India?
To start a pharmaceutical manufacturing company in India, register your business, obtain required licenses, establish GMP-compliant facilities and develop a product portfolio while adhering to strict regulatory guidelines.
Q2. What is QA/QC in pharma industry?
QA (Quality Assurance) and QC (Quality Control) are crucial processes in the pharmaceutical industry QA focuses on establishing and maintaining quality standards while QC involves testing and inspecting products to ensure they meet those standards.
Q3. What licenses are required to setup pharma company?
To set up a pharmaceutical company you generally need drug manufacturing wholesale drug and retail drug licenses along with any required local permits and FDA approval Specific requirements vary by location.