E & E Medicals and Consulting Service Fees
Most clients are always confused about the cost of FDA filings because their signed agreements with other consulting firms include additional fees based on the complicated process involved in answering FDA queries. E & E Medicals and Consulting makes the process very straight forward with fewer closing costs and fewer headaches. E & E Medicals and Consulting helps during the process of submitting applications for class I, II, III medical devices at any stage of the product development. Our team of qualified experts will successfully prepare and submit FDA medical device regulatory documents for the U.S. and international clients. These applications include:
Medical Device Establishment Registration & US Agent Services
For more details, submit your details at Medical Device Registration.
510(k) Applications for Active Devices / Non-active Devices / Implant Devices / Software Devices
Full – Service fee includes:
Half – Service fee includes:
For the FDA 510(k) Full / Half service, provide your details here.
Health Canada Medical Device Establishment License (MDEL) & Health Canada Medical Device License (MDL)
Full – Service fee includes:
For the MDL or MDEL Full service, Request for Quote (RFQ) now!
CE Marking Applications for Class I Devices / Class II-A & II-B Devices / Class IS/M/R Devices / Class III Devices
Full – Service fee includes:
Half – Service fee includes:
For the CE Marking of Full / Half service, provide your details here.
Registration of Devices in Other Countries
Australia / Brazil / Colombia/ Costa Rica / Egypt / Hong Kong / India / Israel / Japan / Malaysia / Mexico / New Zealand / Peru / Russia / Saudi Arabia / Singapore / South Africa / South Korea / Taiwan
For registration of devices in any of the above mentioned countries, Request for Quote (RFQ) now!
ISO 13485, ISO 9001 and ISO 14971 Certifications
E & E Medicals and Consulting will work with your organization in understanding the vital needs of your company processes and prepare you for both Certification and FDA Audits. We shall provide you the following:
For your ISO 13485 needs, click here.
For your ISO 9001 needs, click here.
EU MDR Technical Documentation / Gap Analysis/ Submissions
Our expert’s review device design, risk analysis, clinical evaluation, testing reports, post-market surveillance, labeling, and other required areas. Gap analysis is carried out to ease the transition in the required areas. To meet with the New EU Medical Device Regulation (MDR) in which safety, efficacy, and performance measures are required in technical documentation, many manufacturers with CE Certification under MDD need to convert their documentation to meet the new Medical Device Regulation (MDR). The existing files shall be reviewed and upgraded with quality materials to meet all requirements. The Clinical Documentation process begins with a clearly designed Evaluation Plan which, entails the methodological and systematic approach to reach adequate reporting. It provides a step-by-step approach to conducting and documenting each procedure. In the MDR, Chapter VI, Article 61 the critical issues to be considered for clinical data with regards to general safety and performance are discussed. Our experts have developed forms and templates that can be customized for mandatory procedures of the Clinical Evaluation Record.
For your MDR certification needs, click Request For Quote (RFQ) – MDR Technical Documentation
Drugs
Many pharmaceutical researchers believe that IND and ANDA FDA application submissions are not initially approved most of the time. Our pharmaceutical consultants are expert ANDA Consultants, NDA Consultants and IND Consultants provide our customers with the best possible service. They have the knowledge and experience to increase the chances of receiving initial approval. Our FDA consultants prepare all FDA drug approvals, including:
In comparison to other pharmaceutical consultancies, our experienced accredited regulators have a strong relationship with FDA officials. Let your application be completed by our professional staff or direct you through the FDA application process. The FDA does not only need the safety and efficacy of pre-clinical and clinical data from many pharmaceutical research firms but also investigates the production processes to make sure cGMP standards are met. Our FDA drug consultants will assist you with a well-developed plan for your product application strategy. E & E Medicals and Consulting offers our pharmaceutical customers the following services:
For IND and ANDA FDA Submissions/Applications, Request for Quote (RFQ) now!