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Operon Strategist

About

Operon Strategist is a technical consultancy regulatory advisory company providing consultancy guidance to various manufacturers in the healthcare industry to ensure strategic development of these manufacturers. We serve our clients by providing turnkey services, system implementation, training, licensing, regulatory approvals and certifications.

Latest update

Clean Room Design Consultant For Medical Device:
We helps in the design of Clean Room for any type of medical device as per national and international regulatory requirement. The classified areas are also reflected in the factory layout design to give a better clarity to the client about classified & unclassified areas. We are clean room design consultant , we guide Medical Device manufacturers on supporting elements to maintain the clean room conditions suitable for manufacturing like Entry exit procedures, Gowning procedures etc.
Clean Room Design Consultant For Medical Device: We helps in the design of Clean Room for any type of medical device as per national and international regulatory requirement. The classified areas are also reflected in the factory layout design to give a better clarity to the client about classified & unclassified areas. We are clean room design consultant , we guide Medical Device manufacturers on supporting elements to maintain the clean room conditions suitable for manufacturing like Entry exit procedures, Gowning procedures etc.
view all updates 1513330093

Services

Manufacturing Site Conceptualization
Manufacturing Site Conceptualization INR 0 INR 0 Manufacturing Unit Setup Design Consulting Services For Orthopedic implant Manufacturing Industry , surgical instrument manufacturing , dental instrument manufacturing Industry ,implant-manufacturing , implantable-molding , instrument-manufacturing , endontic-instrument , diagnostic-instrument manufacturing Industry, equipment manufacturing , sterilizers manufacturing , syringe manufacturing , Disposable Plastic Syringes Manufacturers of medical devices like orthopedic implants, disposables and other medical devices, primary packing material & various pharma products have to design their manufacturing unit to meet cGMP requirements & other regulatory requirements. True 1508838029
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Medical Device Project Consultant
Medical Device Project Consultant INR 0 INR 0 Operon Strategist is a leading regulatory & quality assurance consultant for medical device & primary packaging manufacturers. Working out of Pune, India, Operon Strategist has a global presence with an international client base We are Provide Medical Device Turnkey Project Consulting Services In USA, Dubai, South Africa , New York , Qatar, Algeria, Libya, Shri lanka, Austrlia , Mauritius, Costa rica. True 1508837685
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Medical Device Layout Design
Medical Device Layout Design INR 0 INR 0 We study the requirements of the client, the product details & the manufacturing flow process to develop an adequate layout which meets regulatory requirements such as unidirectional flow of man & material, prevention of cross contamination, correct assignment of clean room classification among other requirements. In addition to designing the layout, we also provide qualification & validation services of the utilities, machines & equipment required for the operation of the manufacturing unit. True 1508837774
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Medical Device Clean Room Design Consultant
Medical Device Clean Room Design Consultant INR 0 INR 0 Clean room helps in Establishing & Maintaining an Environment with a low level of environmental pollutants such as dust, airborne microbes, aerosol particles & chemical vapors. Presence of unwanted air particles may adversely affect the performance and safety of a product and hence Medical Device manufacturers are advised to manufacture under classified areas.Clean rooms of different sizes and complexity are designed to maintain low levels of air particles as per the as per the ISO 14644 clean room standards. As a Medical Device clean room design consultant, Operon Strategist helps in the design of Medical Device clean room as per the desired levels of air quality. In addition, to controlling the air particle count, environmental factors such as humidity, temperature, and pressure are also considered while designing a clean room. True 1508837879
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Medical Device Process validation
Medical Device Process validation INR 0 INR 0 Validation is a process of establishing documentary evidence demonstrating that a procedure, process or activity carried out in production maintains the desired level of compliance at all stages. In particular, we provide the following validation services. Validation is an important cGMP requirement & many regulatory agencies audit the validation documentation. Since a wide variety of procedures, processes & activities need to be validated. Operon Strategist guides manufacturers & validation service providers on the validation activity & documentation.We study the product & the production facility & accordingly design the validation master plan which outlines the validation activities to be performed & timeline for the same. We provide guidance for preparing validation protocols & reports in the correct format so as to meet the regulatory requirements including DQ, IQ, OQ & PQ protocols &; PQ report. True 1508837951
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Medical Device Plant Setup Design
Medical Device Plant Setup Design INR 0 INR 0 We are a leading service provider of facility plant setup, medical device unit design, pharma setup and clean room design facility plant setup service offered comprises services handled by experienced Industry professionals who have with them rich process experience and expertise in meeting the demands of plant setup requirements.Services meeting demands of clients looking for expanding their business ,r educe bottlenecks and manufacture new products. True 1508838213
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Equipment utilities validation
Equipment utilities validation INR 0 INR 0 Operon Strategist is a consulting company for medical device industry, primary packing material manufacturing industry& pharmaceutical industry.(Medical device consultant, primary packing material consultant, pharmaceutical consultant) We help manufacturers of these industries to Design Layout as per all international & national guidelines to make your manufacturing unit compliant with all regulatory requirements. syringe manufacturing consultant, orthopedic implant manufacturing consultant , Medical device disposable implant, Medical disposable syringe. True 1508838901
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Design Control Guidance For Medical Device Manufacturers
Design Control Guidance For Medical Device Manufacturers INR 0 INR 0 Medical device design and development is a complex process with specifications, regulations , application requirements , and end user needs all of which must be equivalent and held to for a successful product . if your device reduction usability , market share will suffer. but if your device doesn’t meet regulatory guidelines, it won’t make it to the market at all. During Design and Development stage of the medical device, we assist various medical device manufacturers to meet regulatory compliances of the medical device design and development.Our Company Provide Medical Device Manufacturing Unit Design Consulting Services In USA, Dubai, South Africa , New York , Qatar, Algeria, Libya, Shri lanka, Austrlia , Mauritius. True 1508910901
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Our timings

[IS_BIZ_OPEN] Mon: 10:00AM  -  7:00PM
[IS_BIZ_OPEN] Tue: 10:00AM  -  7:00PM
[IS_BIZ_OPEN] Wed: 10:00AM  -  7:00PM
[IS_BIZ_OPEN] Thu: 10:00AM  -  7:00PM
[IS_BIZ_OPEN] Fri: 10:00AM  -  7:00PM
[IS_BIZ_OPEN] Sat: 10:00AM  -  7:00PM
[IS_BIZ_OPEN] Sun: Closed  -  Closed

Contact

Operon Strategist, MSR Capital, Office No:10, 3rd Floor, Old Mumbai Hwy, Morwadi, Pimpri Colony, Pimpri-Chinchwad, -411018, Maharashtra
+91 8061844079  or   or   
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18.6343222 73.8032812 Operon Strategist Operon Strategist, MSR Capital, Office No:10, 3rd Floor, Old Mumbai Hwy, Morwadi, Pimpri Colony, Pimpri-Chinchwad, -411018, Maharashtra
57ac2b8d9ec6690b1c555a34OPERONSTRATEGIST57c3c1a65d64370d7cf4eb17