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Life science Market Research & Regulatory
Technology portfolio – Lifescience Market Research, Market intelligence database, Techno commercial Global market research and analysis, Medical device, Endoscopy, customized reports for research Institute’s scholars, and different industry.
Primary Industry we serve to:
Pharmaceutical, Cosmetic, food, Medical devices, Life science, Pigment/paint, from Technical data to commercial.
“Life science Techno commercial data – API, Intermediaries, formulation/finished product, patents, route of synthesis, Clinical Trials includes “Trail diligence”, pharmacovigilance, global buyer, seller, Export/import” & much more.
Dossier & DMF – CTD, eCTD, ACTD, country specific guidelines etc.
Predictability and results with medical device companies in complex and challenging growing markets for example like India.
MDR/IVD Regulatory services & Market Research – DMF, PMF as per country specific guidelines.
Predictability and results with medical devices and In-vitro diagnostic medical devices companies in complex and challenging growing markets e.g., India, Europe, USA etc.
Product portfolio we supports for: Medical devices and accessories, In-vitro diagnostic & consumables, Life Science, & surgical items Registration to acquire the license for commercial promotion/sale, “Primarily in India and for some other countries also”.
Medical devices are categorized into four classes: A, B, C, and D, depending on their level of risk. The CDSCO, which is the regulatory body under the Indian Government, charges varying fees for application processing based on the device’s classification. Regardless of the device’s classification, the application process typically takes 6 to 9 months to complete. For products that cannot identify a predicate device, they will be labeled as ‘Innovative,’ and the approval process may require additional time beyond the standard timeframe.
To comply with regulations, all medical devices must undergo registration or obtain an Import License. The list of product types that necessitate an Import License can be found at the bottom of this page. For the specific category of devices termed “Notified,” an Import License is mandatory, and the process involves submitting a Device Master File (DMF) for each product and a Plant Master File (PMF) for each manufacturing site.
Upon successful approval, the medical devices are registered under the Import License linked to the primary manufacturing location. This ensures adherence to the necessary regulatory requirements for the distribution and use of medical devices.
In vitro diagnostic (IVD) medical devices are categorized into four risk-based classes: A, B, C, and D. The CDSCO, the regulatory body under the Indian Government, determines the application processing fees based on the device classification. Irrespective of the device’s category, the application process typically takes 6 to 9 months to complete.
For products that cannot identify a predicate device, they will be designated as ‘Innovative,’ and the approval process may require additional time beyond the standard timeframe.
Performance evaluation reports must be conducted by a local National Accreditation Board for Testing and Calibration Laboratories (NABL) accredited laboratory for registration of IVD medical device in India. Further, performance evaluation reports from the National Institute of Biologicals (NIB) are required for IVD devices and test kits related to:
Paracetamol (acetaminophen or para-hydroxyacetanilide) is a non-opioid analgesic and antipyretic agent used to treat fever and mild to moderate pain. It is a widely used over the counter medication and common brand names include Tylenol and Panadol.
World Odissey LDA expertise of more than a decade with a group of companies principally in professional brand uplifting.