Medical Devices Compliance Service

Service Details:

We are engaged in offering a qualitative Dossier Preparation Service to our valuable clients. We design and implement drug development writing projects specifically tailored to your organization and or products. We use a blend of proven operational methodologies, processes, Standard operating procedures (SOP's), technology, infrastructure, tools, templates and the 'right' kind of human intellect to deliver our projects consistently on time and agreed upon quality guidelines to generate significant ROI.

NKC offers the following services in this area:

• Drug Firm Establishment Registration with US-FDA (FEI No.)
• Drug Listing in SPL format, BULK DRUG Listing
• NDC no. and Electronic submission
• Regulatory filings of Generics IND/NDA/ANDA/BLA/AIDS etc. to US, Europe, Canada and Row market
• Dossier Preparations: Dossier preparation and compilation as per Common technical dossier (CTD/eCTD) format/ Asian Common Technical Dossier (ACTD) Guidelines / South Africa (MCC-MRF-1) Guidelines/ Brazil ANVISA Guidelines/ Commonwealth of Independent States (CIS) Guidelines/ South East / West Europe Guidelines
• Critical Review of Dossier and Preparation of GAP Analysis Report
• Re-formatting old Dossier/DMF, NTA to CTD/eCTD format
• Preparation of DMF/ASMF/ADMF/ CEP or (CoS): Drug Master File (DMF) compilation for open and closed parts
• eCTD preparation for EU Submission
• Technical Support in CMC-Writing, SOP Writing, Protocol Writing, Expert report (QOS) preparation
• Technical writing of Specifications, Test Procedures, Method/ Process Validation Protocols/Reports, BMR/BPR, Manufacturing Formula, and Process
• Preparation of Summary of Product (SPC), Pack Insert, Product rationale

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Service Details:

We are the well-reckoned name, engaged in offering 21 CFR Parts 820 Compliance Service to our clients. The process also involves coordinating with various government bodies for obtaining statutory requirements and informing the client about any changes in the legislations to ensure complete compliance. 

Features:

• Secured audit trail (User, Equipment, Alarm SMS, Events)
• E-Records and E-Signatures with Date and Time stamp
• MKT (Mean Kinetic Temperature)
• Unlimited equipments connectivity
• Real time analysis
• Graphical Analysis
• First time user login change password
• Password Encryption
• Alpha numeric password and password ageing
• System Administration
• Authorized Multilevel Username and Password
• Data Acquisition
• Offline analysis (in Tabular and graphical analysis)
• Open door with reason master
• Data generated on PDF format
• Realtime parameter setting
• MY SQL (RDBMS) Database
• Automated Back Up Facility
• Auto logout, account Blocking and reactivating facility
• Log data, event and audit trail data recording

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Service Details:

Audit Compliance Service offered are handled by experienced professionals from the industry who have with them rich process knowledge as well as in-depth experience so as to flawlessly handle the audit compliance demands. The up-to-date knowledge base of the team also allows them to perfectly understand and handling new changes in regulations, audits, and compliance as per the changing regulatory requirements. 

 

Some of the features include:

• Supporting clients in keeping pace with data collection, control frameworks
• Provide clients complete peace of mind while our dedicated team handles all standard and industry-
• specific audits
• Supporting demands of managing relationships with external auditors
• Service levels delivered meet stringent and demanding requirements
• Support offered for compliance with government laws and regulations
• Accurate and thorough reporting of information
• Help clients understand varied and evolving compliance needs

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Service Details:

Regulatory Licensing Service offered are handled by experienced professionals from the industry who have with them in-depth knowledge as well as wide experience in flawlessly handling the Liaoning demands. The services are especially important as it allows clients to perfectly understand and work in accordance to business culture and government regulations which reduce the risk factor involved with businesses.

 

Some of the features include:

• Support reducing the risk and cost involved
• Allowing for smooth launch of company and products
• Taking care of all approvals
• Dealing with all regulatory issues like product development and commercialization
• Getting export and import licenses
• Supporting product registration and documents attestation

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Service Details:

Clients can avail from us, Company Regulatory Audit Compliance Service at reasonable prices, that aim at small to mid-sized organizations and also, large sized companies, who want to have an Independent support. Rendered by a team of qualified and competent professionals, these services are appreciated by the clients for their flexibility and reliability.  

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Additional Information:

• Pay Mode Terms: T/T (Bank Transfer)