Consultants for EUROPEAN & US FDA rules applicable for Medical Device, Drugs, Food & Cosmetics.
A drug master file (DMF) is a confidential, detailed document submitted by Active Pharmaceutical Ingredient (API) manufacturers to the U.S. Food and Drug Administration (FDA). A DMF contains the chemistry, manufacturing and controls of a drug component.
US FDA Drug Master File
US DMF is required to supply bulk materials to the United States but the FDA does not require all manufacturers to submit a US FDA DMF.
However, the information contained in a FDA DMF may be used to support an IND), NDA, ANDA, another DMF, an Export
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Benefits of ISO 13485 Certification.
Medical device manufacturers MUST improve business with ISO 13485 certification:
Access to markets that recognize or require the certification
Reduce operational costs by highlighting process deficiencies and improving efficiency
Increase customer satisfaction by consistently delivering quality products and systematically addressing complaints
Proven commitment to quality thereby Certifying your company
Adds transparency to the way complaints, surveillance or product recalls are handled
ISO 13485 Certification
In Europe, ISO 13485 (or EN ISO 13485) is seen as the standard for the medical device industry.
ISO 13485 was first implemented in Europe, Although ISO 13485 certification is voluntary, obtaining certification allows you to meet the quality system requirements of the European Medical Device Directive (93/42/EEC), In Vitro Medical Device Directive (98/79/EC) and Active Implantable Medical Device Directive (90/835/EEC)
Proper Implementation of ISO 13485 helps medical device manufactures to affix CE faster.
To know more about CE and ISO Certification please contact I 3 Consulting in Bangalore
EN ISO 13485:2012
All requirements of ISO 13485 are specific to organizations providing medical devices manufacturing and distribution regardless of the type or size of the organization
If any requirement(s) in Clause 7 of ISO 13485 is (are) not applicable due to the nature of the medical device(s) for which the MDQMS is applied, the organization does not need to include such a requirement(s) in its QMS.
The ISO 13485 which are applicable to the medical device(s), but which are not performed by the organization, are the responsibility of the organization and are accounted for in the organization's quality management system.
I 3 CONSULTING helps to implement ISO 13485 faster. Contact us
EN ISO 13485:2012
ISO 13485 specifies requirements for a quality management system (MDQMS) where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.
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Medical Device Manufactures has to Implement EN ISO 13485:2012 and Followed by CE Certification to sell there products in Europe and across other parts of the world.
CE Certification is considered as one of the minimum standard requirement in INDIA also.
CE Certification is for your Medical Product. Not for the Company.
CE Certification will be provided for the device, model and its variants
CE Certification is possible only when you demonstrate your compliance with International standards, Product specific standards, and European Harmonized Standards.
CE Certification- the certificate will be issued by Notified Body from Europe.
More information about the process and requirement, please contact
What are the benefits of Self certification?
CE Self certification is limited with class 1 medical devices only.
This is a easy route to comply with CE Marking regulations.
How do you benefit from CE marking?
The CE marking is a kind of trade passport for the European marketplace: it allows the manufacturer to freely circulate their product throughout the 30 European countries
The great benefit for manufacturers is that there is now only one set of requirements and procedures to comply with in designing and manufacturing a product for the entire 30 countries.
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Our FDA DMF Submission Scope.
Option 01 Documentation and Technical Consultancy.
Provide a checklist containing documents to be provided by client to consultant for the DMP Preparation.
Preparation of Drug Master File for submission. ( Exclusive feature)
Identification of records, reports, chemistry needs to furnish in the submission file(for type II DMF and III DMF).
Edit and organize DMF information as per FDA required format.
Completed FDA DMF for review and acceptance by the client.
Guidance on GMP.
We are US Agents and Consultants for US Food & Drug Administration ( US FDA) regulatory compliance.
Our services are used by 1350+ manufactures & Exporters in India. We are the only Indian company operating from INDIA.
How we differ from other foreign companies and franchise operating in INDIA.
1 Offices located in Bangalore, Florida & Chicago.
2 Client has the choice of interacting with technical team before taking a decision.
3 Online application Filling with guidance of an expert.
4 Application processing is very fast as our office function 24 x 7 - 6 days a week.
5 Payment option in INR by RTGS , PayPal or Instamojo.
6 Maximum processing time for FOOD registration is 4 Hrs. and Medical Device /Drugs is 14 days.
7 Lowest Fees in INDIA
We also provide FDA pre Inspection GAP analysis and Guidance for Food, Cosmetic, Nutraceutical & Medical Device manufactures.
Kindly consider us for your future requirements.