Operon Strategist
Operon Strategist
Pimpri Colony, Pimpri Chinchwad, Maharashtra
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Medical Devices Import Licensing Services

Providing you the best range of import licensing services and import & product registration for medical device with effective & timely delivery.

Import Licensing Services

Import Licensing Services
  • Import Licensing Services
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Service Details:

Import / Export LocationIndia
Product Weight / SizeAs per Requirment
Type of Service ProviderCompany

Our company has created a niche in the field of providing Import Licensing Services to the clients. This service is widely known across the industry for perfect compilation standards. The offered range is widely appreciated for client specific resolution. WPC Import License is executed by a team of experienced professionals who have deep and thorough knowledge in this field by using superb techniques. Offered service is widely appreciated for consistency and personalized approach. This service is much appreciated all across the nation for timely completion and hassle-free management and is widely appreciated by clients.

 

Features:

  • Efficient execution team
  • Applied Latest methodology
  • Rendered by a team of expert professionals
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Import & Product Registration for Medical Device

Import & Product Registration for Medical Device
  • Import & Product Registration for Medical Device
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Operon strategist can assist Medical Devices , Foods , Cosmetics companies for registration and licensing .In Case your company is large or small , domestic or foreign, we have the ability to direction your regulative needs.

FDA Regulatory Consulting ,Submission and Auditing Services:

The operon strategist consists of proficient who know what FDA and other regulatory bodies desire of pharmaceuticals, medical devices, foods, cosmetics, dietary supplements and other managed products provide for sale in the United States or other countries throughout the world.

Operon strategist offers a range of Medical Device consulting, submission and auditing services including:

Preparation and submission of 510(k) pre-market notification to FDA approval.

Conducting quality system audits of medical device manufacturers.

Assistant medical device manufacturers for implement quality control/assurance, regulatory affairs, Handling compliant, document.Operon strategist provides the following services for FDA Registration

  • Import Registration of Drugs.
  • Medical device manufacturing site Registration.
  • New Product License formanufacturing in India.
  • Cosmetic registration for import in india.
  • Medical Device Registration Consulting.

Manufacturing License in india

Our experienced professionals are familiar with all aspects of medical device regulatory compliance in India. Our services include obtaining Manufacturing License for medical devices in Form-28, medical device registration & approval for foreign manufacturers in Form 41 and import licenses in Form 10, Test license to manufacture drugs for purposes of examination, teat or analysis.

Manufacturing License in form 28 (For Indian Manufacturer)

  • Providing guidance to develop your manufacturing premises as per Schedule M- III.
  • Guidance for facility design.
  • Guidance for preparation and execution of equipment validation activity.
  • Guidance for preparation of complete documents.
  • Preparation and submission of application to CDSCO, Zonal and state drug controlling authorities.
  • Providing complete support during inspection and audit.

Medical Device Registration Certificate in Form 41 (For Foreign Manufacturer)

  • Determine your devices are comes under the list of notified Medical Devices regulated under Drugs and Cosmetics Act, 1940; and Rules, 1945.
  • Coordinate the device registration and approval process with Indian Medical Device Regulators (DCG(I)/CDSCO).
  • Guidance for Preparation of all necessary documents for the product registration application including Forms 40.
  • Assist to appoint an Indian Agent as your official representative.
  • Submission of Site Master File and Device Master File as needed.
  • Coordinate with the DCG(I)/CDSCO to address follow up questions and monitor progress.

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Additional Information:

  • Minimum Order Quantity: 1 Unit
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Reach Us
Anil Chaudhari (Proprietor)
MSR Capital, Office No. 10, 3rd Floor, Old Mumbai Pune Highway Morwadi, Pimpri Colony
Pimpri Chinchwad- 411018, Maharashtra, India



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