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Blog Posts (2)

  • FORM MD-3 & MD-5: License for Manufacturing Class A&B & Form MD-26 for New Medical Devices

    The medical device industry is one of the fastest growing and most important industries in health care that brings innovation and new technologies. The med-tech sectors make huge investments to make good quality and innovative medical devices to provide the best possible treatment to patients. Licensing is a vital procedure for any medical device manufacturing company to ensure that the device is free from vulnerabilities or harmful effects. Medical device licensing in India is done by Central Drugs Standard Control Organization (CDSCO). The devices are granted licenses based on their categories. Applications for Manufacturing Licence in India The companies that manufacture Class A or Class B medical devices have to go through a procedure by applying for a license to sell or distribute medical devices. These manufacturers have to apply to the State Licensing Authority for approval from the Ministry of Health and Family Welfare's online portal, depending on the applicant's location. In India, form MD-3 and Form MD-5 are required to obtain permission to manufacture Class A-B medical devices. Apart from these forms differ based upon the intended purpose of application.  Form MD-26 is the manufacturing license of innovative or new medical devices being registered for the first time in India. Central Drugs Standard Control Organization (CDSCO) is the regulatory authority of India that grants permission to manufacture/import new medical devices in India. What is MD-3, MD-5 & MD-26? MD-3 is the application form. By this application form, an MD-5 license is given to manufacturers for a license to manufacture and sell Class A or Class B Medical Devices. Form MD-26 is the application form through which manufacturers can get permission from CLA either for manufacturing/importing medical devices that do not have predicate devices in India The next steps After the collection of the required documents, below are the steps that are to be followed: Inspection of Application It is one of the most important steps of the process as if any shortcoming/discrepancy is noted, a query shall be raised. The application moves forward when the reply to the query is received from the applicant. Audit of applicant premises After the successful scrutinizing of the application, an audit report and the notification of closure of the applicant’s premises are prepared by the Central Drugs Standard Control Organization (CDSCO). After the audit report is submitted, it is reviewed and if found acceptable, it is moved forward for further process. Scrutiny of the products The products for which the application is applied are then evaluated. If they are found in accordance with the norms, the application will be considered for grant of a license The permit of license The license is granted with the validity of 5 years on the attainment of all the laid down prerequisites How Rihim Pharma can help? Rihim Pharma has a team of experts that can help in the pre-screening of all the documents that are needed to make sure that they are free from any errors or need any updates necessary according to India’s updated norms or recent changes. Although manufacturers can collect all the documents to be submitted but knowing the correct way of presenting information is also a necessity. We can help you in the pre-screening of the application before its submission so that it is free from any disparity and can help you to reply back in case any queries are raised on the application and resolve any non-compliances with the application. Any individual or company involved in the manufacturing of medical devices needs to obtain a manufacturing license for medical devices. Sometimes, this can be a tedious process for them. Rihim Pharma has a technical team that helps manufacturers to study their products to create the best possible route, making the approval process easier for the manufacturers. We have a redesigned checklist and processes that have simplified the registration formalities for the clients to make the process smooth which ultimately speeds up the timeline for getting the approvals. To know more, connect with our team at info@rihimpharma.com

  • New Drug Application Can Boost Your Manufacturing Business, Read How!

    New Drug is any molecule or Fixed Dosed Combination (FDC) which is registered for the first time in India. The registered drug is referred to as a “New Drug” for 4 years after the date of first approval. The first application requires a clinical trial, whereas the subsequent applications can just go with the Bioequivalence (BE) studies which are much cheaper and faster. Who regulate drugs approval in India? In India, Indian Parliament proclaimed The New Clinical Trial Rules & Amendment 2022 in order to regulate the import, manufacturing, distribution, and sales of new drugs. CDSCO is India’s drugs regulatory body for pharmaceuticals, medical devices, and cosmetics was established along with its licensing authority, the Drug Controller General of India (DCGI). How Do New Drugs Impact Business? New Drugs helps to create a portfolio of uncommon, new, and trending products. Big pharma and marketing partners often look for the manufacturers with new drug or products The DCGI publishes a list highlighting companies that have received New Drug Approvals, which can benefit the branding of the company With the new drugs the company can standout and it will help in extra edge over other companies. There are not many companies that have the resources for filing New Drug Application. How Regulatory Specialists help in Regulatory Filings? Regulatory affairs play an important role in the pharmaceutical industry to oversee the sanctity of the procedure and the formulation of a drug. In terms of regulatory filings, the procedure of the drug passing through regulation from the date of filing till approval is a hectic and elongated procedure. Applying a new drug for approval demands a variety of different documentation. Primarily, there are two reasons behind the failure of drug applications, one of them being unsatisfactory information provided to the regulatory body and the other being inadequate drug performance. Thereby refining and executing the regulatory strategies in an organized manner becomes necessary to achieve a positive resolution. To guide companies or organizations through these procedures is where a regulatory specialist turns out to be useful. A regulatory consulting specialist works by helping a company or organization meet the necessary regulations that are required for its products. The following are some of the tasks and responsibilities of regulatory specialists: Providing a deep understanding of new and existing regulations impacting the organization’s products and procedures Establishing clearly documented protocols Explaining regulations, procedures, and policies to the employees and stakeholders as necessary Reviewing marketing, legal, and technical documentation to assess compliance Regularly reporting on compliance status and measures to both internal and external parties Acting as a link between the organization and the state, local, federal, or international agencies in order to submit the required forms and paperwork in a simplified manner How can Rihim Pharma help you? Developing a new drug not only takes a lot of resources but a great amount of effort added to it and thereby taking a drug to its end goal, the consumers, demands a lot of effort and patience. Any new drug in India must follow a specific procedure and submit several documents in order to be approved by the CDSCO. We at Rihim Pharma will help guide you through each stage of this procedure. Rihim Pharma is determined to provide a simpler and hassle-free experience to our clients. Here is a glimpse of some of the services you will receive from our end: New Drug suggestions based on existing portfolio and manufacturing capabilities Managing end-to-end regulatory affairs from the compilation of the documents to submission and approval Help in sub-contracting CT/BE/Toxicity studies and with our great experience in SEC, we can help you prepare for the SEC GAP analysis of documents to reduce queries in NDA Creating a regulatory strategy that gives your business an edge Rihim is doing this for over 500+ Pharma Companies, see our clientele

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  • Rihim Pharma Consultancy (India) - Regulatory Consultants

    HOME SERVICES ABOUT US CLIENTS FACTS CONTACT HOME YOUR PERSONAL PHARMA REGULATORY DIVISION WITH INDUSTRY-CLASS EXPERIENCE REGULATORY CONSULTANCY FOR INDIA (CDSCO/DCGI) Our Services Related to Medical Devices & Diagnostic Kits We are providing end-to-end regulatory services for Medical Device importers, manufacturers and supplies. Our team is experienced for swift regulatory submissions and approvals. TALK TO US PHARMA (DCGI) NEW DRUGS CT NOCs MFG. APPROVALS COSMETICS IMPORT REGISTRATION MFG. APPROVALS FOOD & NUTRACEUTICAL PRODUCTS (FSSAI APPROVALS) MEDICAL DEVICES & VACCINES VOLUNTEER REGISTRATIONS SERVICES OUR SERVICES Create a regulatory strategy There are numerous ways to proceed for each kind of product. Our technical team will study your products upon which we will create a route best fitted for getting approvals of products from Indian Authorities. Our team will predict possible challenges and create a strategy to overcome them. Pre-screening of documents Information presented rightly accelerates the timeline and reduces complexities. Our experienced technical team audits each document for any errors, updations or information that is necessary for India’s updated norms, validating them with recent changes or authoritative texts. Timeline Management We will make sure that everything keeps moving and fetch results under best timelines. A project coordinator from our company will collaborate with your team to assist you over the documents and perform regular follow-ups — a culture that has been valued by most of our clients. On-demand Services En-route there are several other services which we offer as the need comes. Our team can handle your CDSCO Correspondences, prepare justification rationales, research and format replies to queries, market insights, networking, online and offline submissions, PV Services, general assistance and more. AREA OF SERVICES NEW DRUG APPROVALS FDC APPROVALS IMPORT & REGISTRATION GLOBAL CLINICAL TRIALS BA/BE NOC VACCINES/ BIOTECH PRODUCTS COSMETICS' IMPORT REGISTRATION MEDICAL DEVICE IMPORT REGISTRATION NUTRACEUTICALS/FOOD SUPPLEMENTS APPROVAL - FSSAI ETHICS COMMITTEE REGISTRATION WHO WE ARE Rihim Pharma Consultancy is an extension of any Pharmaceutical company which can take care of complete Regulatory Affairs in a smooth and promising way. Rihim Pharma is a team of certified pharmacists, experienced managers and a vibrant co-staff. It has been more than a decade that we are continually specialising our portfolio, easing out the way for hundreds of our clients and achieving enormous satisfaction for them. Although we may be a regulatory company, but in no way we ignore the sciences behind your product. Rihim Pharma has always believed that science should not be altered for coping with other challenges. And so, our team is specifically aligned towards keeping an eye on science of the drug along with the other duties. Our clientele is always ensured of the trueness of the work we begin. ​ An ISO 9001:2015 Certified Company ABOUT US CLIENTS OUR CLIENTS We have always been there as a part of our clients' own division. We have enjoyed working with a more than 300 Pharma giants and have succeeded to serve efficiently. Here are some of our long-time and popular clients... Amgen Logo-Menarini_CS takeda-shire-7x4 Logo_of_PT_Bio_Farma_(Persero) 5856a7bb4f6ae202fedf276b Dabur_Logo.svg logo Advanced-Hair-Studio-in-Ahmedabad 003-APTOS-new fresenius Logo shah distributers LAMBDA_LOGO_png veeda logo logo-2 granules India logo.jpg 103575-rb naprod ALKEM Signet Screen Shot 2018-08-27 at 12.35.30 PM logo-1 umicore logo_15 ambeal Screen Shot 2018-08-27 at 12.40.21 PM default Screen Shot 2016-01-26 at 11.05.32 PM innova-logo logo-1 118_RIVPRA_FORMULATION_PVT.LTD EuMUIbuVkAQwBMA omron logo 1573755321274 1519864698368 FACTS 8000+ SUBMISSIONS 300+ CURRENT CLIENTS 100% SUCCESSFUL APPORVALS FACTS CONTACT Send us your enquiry First Name Last Name Email Company Write a message Submit Thanks for your enquiry! Our team will get back to you soon. Lets work together. Brief us about your requirements. 518-519, Ring Road Mall Rohini Sector-3 New Delhi, India - 110085 info@rihimpharma.com 011-47564040 or +91-9891072226

  • We're Hiring! | rihim-pharma

    WORK FOR QUALITY REGULATORY PROFESSIONAL M. PHARMA (DRA) Undertake regulatory submissions to DCGI Compilation of application as per checklists Coordinate with clients to resolve their queries and follow-up for on-going projects Able to communicate with new leads and thrive to materialise them Team up with technical experts in the office and solve challenges regarding Regulatory Affairs Package: 3 Lakhs p.a. (1-2 Years Experience) 1.80 Lakhs p.a. (Fresher) Apply now

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