Service Details:
Target Location | Pan India |
Document verification Mode | Online |
Services offered | Training |
Mode of Report | Hard Copy |
Type of Certification | New Certification |
Type of Industry | Manufacturing |
Type of Service Provider | Consulting Firm |
Service Details:
Location | India |
Type Of Service | New company registration |
Type of Industry / Business | Medical Device,Pharmaceutical,Chemical Industries,Plastic Industries |
Type Of Service Provider | Individual Consultant |
Project Duration | 2 Months |
Mode Of Service | Online |
Drug Master File Preparation Service is a mechanism that primary packaging manufacturers can use to share confidential information with health authorities without disclosing that information to the pharmaceutical industry. In the US, Drug Master File (DMF) is a submission to the US FDA that may be used to provide confidential detailed information about facilities, processes or articles used in the manufacturing, processing, packaging & storing of one or more human drugs. A DMF permits the sponsor to incorporate the information by reference when submitting an application.
Service Details:
Target Location | Pan India |
Document verification Mode | Online |
Training Courses (if applicable) | Internal Auditor Training |
Services offered | Consultancy |
Mode of Report | Hard Copy |
Type of Certification | New Certification |
Service Details:
Minimum Order Quantity | 1 Set |
Type Of Services | Online |
Type of Service Provider | Consulting Firm |
Type of Industry | Manufacturing |
Type of Service Contract | Retainer Based |
Cost | Standard |
Service Location | PAN India |
Peron Strategist audits the existing CAPA Management system of clients & determines how effective it is in identifying & correcting quality problems.An effective corrective & preventive action system enable easy collection & analysis of information. This information is used identify & investigate existing & potential product & quality problems.
We also guide manufacturers in establishing an effective adverse event reporting system so that information regarding an adverse event/reportable event can be easily conveyed to regulatory bodies as well as the public.
After identifying a recurring quality problem, root cause analysis is done to identify the root cause of the recurrence. Once the root cause has been identified suitable corrective &/or preventive actions can be taken to avoid future recurrences
Service Details:
Type Of Industry | IT and Consulting |
Type Of Services | Online |
Company Type | Consulting Firm |
Type of Service Provider | Consulting Firm |
Type Of Service Contract | One-Time |
Cost | Standard |
Service Details:
Target Location | Pan India |
Document verification Mode | Online |
Type of Certification | New Certification |
Type of Industry | Chemical |
Service Details:
Preferred Location | India |
Type of Industry | Manufacturing |
Service Duration | 7 Days |
After conceptualizing a new medical device, the next step in its product advancement is the design.This is the most important stage in the advancement of a medical device since a defective plan may prompt it being inadequate or dangerous (that is, not affirmed or cleared by the administrative organization).
At the design stage, an outline Control process should be started and actualized as a feature of the quality system requirement. Generally, outline controls are straightforward and logical steps to ensure that what you develop is what you meant to develop, and that the last item lives up to your client’s needs and desires.
Design and Development Planning: Build up and maintain a plan that describes the design and development activities and allocates the individual obligations for each activity. Guarantee you review, update and approve the plan until the device design is completed, verified and validated.
Design Input: Utilize performance, safety, business economics, outputs of risk management and regulatory requirements as a basis to plan the device with the goal that its motivation and the proposed utilize are clear. Input may also come from surveying your customers( For example , clinicians , nurses , patients).
Design Output: Design output methods or particulars need to stipulate or refer to the design input document developed by the team and need to identify the critical measures/outputs for the best possible capacity of the device. These incorporate the tests and strategies that may have been produced, adjusted or used to show conformance with the characterized configuration inputs.
Design Validation: Approve the device design plan by means of examination and target prove, affirm that the last outline yield reliably meets the particular planned utilize. Design validation should follow successful design verification.
Design Changes: Guarantee that all plan changes are distinguished, documented, approved, verified, reviewed and endorsed before usage.
Design Transfer: Ensure that the design of the medical device can be correctly translated into production specifications (that is, advancing successfully from product development to manufacturing).
Design History File: The design history file (DHF) aggregates confirm (that is, the history of the design) that demonstrates that the outline was created as per outline controls???specifically , the design and development plan , or the outline change design.
Service Details:
Brand | Own |
Type Of Ownership | Private Limited |
Type Of Industry | Manufacturing |
Type Of Services | Online |
Location | India |
Country of Origin | Made in India |
Clinical Evaluation of Medical Device is the assessment & analysis of clinical data pertaining to a medical device to verify its clinical safety & performance.Operon Strategist helps clients prepare a comprehensive clinical evaluation report by identifying the general safety & performance requirements that require support form relevant clinical data.We comb through various scientific databases such as PubMed , Cochrane etc. to search for available clinical data relevant to the device & its intended use.
Handling Customer Complaints: Medical device manufacturers ultimate user is the customer whose satisfaction in using a particular product is of utmost importance.Hence an efficient method of receiving & documenting customer complaints must be implemented. Moreover, detailed investigation must be carried out to determine the reason for the customer complaint & accordingly suitable corrective &/or preventive action must be implemented.
Service Details:
Location | India |
Type Of Service | New company registration |
Project Duration | 5-7 Days |
Type of Industry / Business | Medical Device Industries |
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.
Service Details:
Target Location | Pan India |
Document verification Mode | Online |
Services offered | Consultancy |
Mode of Report | Hard Copy |
Type of Certification | New Certification |
Type of Industry | Chemical |
Service Details:
Site Location | India |
Type of Service Provider | Consulting Firm |
Service Duration | 5-6 Days |
Service Mode | Offline |
Clean Room Design Consultant helps in Establishing & Maintaining an Environment with a low level of environmental pollutants such as dust, airborne microbes, aerosol particles & chemical vapors.
Clean Room Design consultant are offered on a one time fee basis or as several visits over time for a specific clean room project. With effective completion of over 50 Clean room projects, CAT conveys an unparalleled advisor experience level to your organization and to your personnel requiring particular guidance and proposals .Our team can give Auto CAD Clean room design services for most Clean room projects fo Manufacturing Industry, Building, Basic, Mechanical and Electrical controls.