Operon Strategist
Operon Strategist
Pimpri Colony, Pimpri Chinchwad, Maharashtra

Medical Devices Project Consultant Service

We are the leading technical consultant and regulatory advisory service provider for healthcare sector. we offer the expertise to help you setting up new Drug Master File Preparation.

DMF Preparation Service

DMF Preparation Service
  • DMF Preparation Service
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Approx. Price: Rs 1 / SetGet Latest Price

Service Details:

Minimum Order Quantity2 Set
Preferred LocationIndia
Usage/Applicationfor pharma companies
CertificationRenewal, New Certification
IndustryAny, Drug, Chemical, Food, Manufacturing

Operon Strategist will provide service for DMF Preparation Service. Additionally, these services are offered at clients end within the predetermined time period. We offer these services to our client's at nominal rates in order to conquer their trust and reliability.
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DMF Certification Service

DMF Certification Service
  • DMF Certification Service
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Service Details:

Minimum Order Quantity2 Unit
Preferred LocationIndia
CertificationNew Certification, Renewal
IndustryChemical, Manufacturing

Operon Strategist provide service for preparing DMF Certification Service to the Food and Drug Administration (FDA) that may use to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs and after compilation and submission DMF to FDA then manufacturer get a DMF number and it will be shared by their potential customers.
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Medical Device Plant Setup Design

Medical Device Plant Setup Design
  • Medical Device Plant Setup Design
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Service Details:

Minimum Order Quantity1 Unit
ModelMedical Device
Type of Industry / BusinessMedical Device Industries
BrandMedical Device

Now a day for the market need, medical device companies pursuing commercialization to a global regulatory strategy. We offer strategic guidance and support at every stage of the product manufacturing and development process.

Our regulatory experts have specialized knowledge of the many regulatory jurisdictions, including Indian and foreign country regulation. Our support ranges widely, including Layout preparation, Layout submission to local authorities, CE marking, ISO 13485, ISO 15378, US FDA medical device classification, pre-approval inspections and FDA District Office meetings.

How We Work

OPERON provides regulatory support in multiple ways:

· provide consultation and advice as standard regulation

· Functioning as a virtual regulatory and QA department to meet Regulatory Norms.

· Providing emergency response teams for query resolution by conference calling, recall handling or audit responses

Other Needs

Through the years, we’ve supported hundreds of clients seeking regulatory designations, approvals, and international registrations. Our other services include:

· Device classification as per Rules

· Guidance for equipment procurement

· Import and export requirements

· Labeling and advertising review

· FDA meetings

· Real-time reviews

· International registrations and submissions

· Device listing and establishment registration

· Creation of technical files

· Post-market support

· Recall planning and management

· Medical device reporting and complaint handling

· Inspection advice and management

· Quality Systems training — individual or small group, management or production

· Perform due diligence assessments

· Audit preparation, training for perusal.

· Preparing and developing SOPs

· Online training to maintains the system update.

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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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