Indivirtus Healthcare Services
As a Contract Research Organization (CRO), Indivirtus Healthcare Services offers a wide range of services within the pharmaceutical and healthcare sectors. Initially, the company specialized in delivering Toxicological Risk Assessment Reports to pharmaceutical manufacturers. However, over time, it has expanded its service offerings to include numerous other services.
Established in 2018, Indivirtus Healthcare Services began its journey in a modest single-room office, staffed by just two individuals, led by Dr. Upendra Jain and Ms. Veena Kumari. Over the span of six years, this humble organization has evolved into a group of five companies, boasting seven offices worldwide and a workforce of over 100 employees. Indivirtus Healthcare Services has successfully served more than 500 clients across over 45 countries.
The range of services provided by Indivirtus Healthcare Services includes:
Toxicology:
Toxicology is the scientific field that involves the study of the harmful effects of chemicals on living organisms.
Cleaning Validation: This service ensures cleanliness to prevent contamination during production processes. It is achieved by calculating MACO (maximum allowable carryover) values based on health-based exposure limits such as PDE (Permitted Daily Exposure), ADE (Allowed Daily Exposure), and OEL (Occupational Exposure Limit), all established through thorough risk assessments. These reports adhere to guidelines set by EMA, ICH, APIC, AND PICS.
Genotoxic Evaluations of Impurities: Utilizing ICH M7 guidelines, this service assesses the genotoxicity and mutagenicity of impurities to determine their acceptability in drug substances and products.
Material Safety Data Sheets (MSDS): These provide detailed information on the safety and handling of materials.
GRAS Reports: These confirm the safety of substances for their intended use.
Regulatory Affairs/Regulatory Affairs (RA/Reg Affairs)
Preparation and Submission of CTD, ACTD & e-CTD Dossiers
Dossiers for Regulated, Semi-regulated, and WHO Regulated Market
CEP Filing & Submission on the EDQM Portal and DMF Filing to the FDA
Clinical & Non-Clinical Overviews and Summaries
Batch Releasing & Testing Site Service for Europe (BRS & BTS)
MAH & Local Agent Service for Europe & US
Pharmacovigilance and Drug Safety Services
PSMF Management
Single Case and Adverse Event Reporting
Aggregate Report Generation
Safety Physicians Support
Signal Management & Safety Surveillance
Literature Monitoring (Global and Local)
Medical Writing
Risk Management Plans (RMPs)
Electronic Submission Management
Medical Information Call Centre (MICC)
Qualified Person for Pharmacovigilance (QPPV) Support
Regulatory Authority Requests and Audit/Inspection Readiness
Social Media Monitoring for Adverse Events
Calibration Services
Indivirtus Healthcare Services is equipped to provide a variety of calibration services through a facility accredited by NABL (National Accreditation Board for Testing and Calibration Laboratories) (ISO/IEC: 17025:2017). Our calibration services cover a broad spectrum, including:
Calibration Facility in various dimensions, pressure, mass, volume, RPM, sound, electro-technical, and thermal.
Temperature Mapping and Validation Facility for Furnace, Chambers, Oven, and Cold Storage.
On-site Facility for Calibration.
Training on Quality Systems & Implementation.
Computerized System Validation (CSV)
Indivirtus Healthcare Services is dedicated to providing comprehensive services in CSV to ensure that systems are performing their intended tasks effectively. Our CSV services include:
Implementation and Validation of Computerized Systems.
Decommissioning of Computerized Systems.
Cloud Systems Validation.
Quality Systems for IT Departments and IT Service Suppliers.
Quality Systems for Software Validation.
Computer Infrastructure Qualification.
Audits for IT Solution Suppliers.
Training.
Clinical Research & Equivalence Studies
Indivirtus Healthcare Services provides a range of clinical research services, including feasibility assessments, participation in regulatory discussions, project oversight, management of clinical sites, handling of data and statistical analysis, and the conduct of Phase I, II, III clinical studies.
Technology Transfer (Tech Transfer)
Indivirtus Healthcare Services specializes in technology transfer services, facilitating the transition of drug substance production processes from research laboratories to commercial facilities. Our services include CMO (Commercial Manufacturing) site transfers and CMDO (Research and Development to Commercialization) services. We handle various aspects of technology transfer, such as:
Site transfers
Research and Development/Funding and Development
Dossiers/Know-how
Good Manufacturing Practices (GxP) and Auditing Services
Indivirtus Healthcare Services offers a variety of audit services to help identify and address deficiencies in processes, ensuring compliance. Our audit services include:
Internal audits and Good, Environment, Management, and Business Analysis (GEMBA) sessions
Third-party audits and Gap assessments
Pre-inspection and Due Diligence audits
Additional Services Provided by Indivirtus Healthcare Services include:
CMO/CDMO Facilities for the Sourcing of Formulations and Active Pharmaceutical Ingredients (APIs)
Greenfield/Brownfield Development Projects
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Walk-In Interviews at Shilpa Medicare Ltd, Hyderabad
Walk-In Interviews for Pharma Professionals at Shilpa Medicare Ltd, Hyderabad
Shilpa Medicare Ltd is conducting walk-in interviews for various positions in Quality Control and Regulatory Affairs. This is an excellent opportunity for pharma professionals looking to advance their careers in a dynamic and innovative environment.
Open Positions
1. Quality Control (Formulation)
Location: Hyderabad
Designation: Executive
Qualification: M.Pharm, B.Pharm, MSc, BSc
Experience: 1-4 years
Key Skills:
Method validation and transfer
Analysis of FP & GLP stability
2. Regulatory Affairs - RoW (Rest of the World)
Location: Hyderabad
Designation: Sr. Executive / Asst. Manager
Qualification: M.Pharm, B.Pharm, MSc
Experience: 6-10 years
Formulation Experience Required
Key Skills:
Preparation, compilation, and review of dossiers for RA RoW region in CTD/ACTD and country-specific formats
3. Regulatory Affairs - EU (European Union)
Location: Hyderabad
Designation: Sr. Executive / Asst. Manager
Qualification: M.Pharm, B.Pharm, MSc
Experience: 6-10 years
Formulation Experience Required
Key Skills:
Preparation, compilation, and review of dossiers for RA EU region in CTD/country-specific formats
4. Regulatory Affairs - Canada
Location: Hyderabad
Designation: Executive
Qualification: M.Pharm, B.Pharm, MSc
Experience: 2-5 years
**Experience Required in Any Regulatory Region
Key Skills:
Preparation, compilation, and review of dossiers for the Regulatory region in CTD/country-specific formats
Interview Details
Venue:
Shilpa Medicare Ltd
Plot No. 79, Road No. 15, Survey No. 125, IDA Mallpur, Nacharam, Uppal, Mandal, Telangana 500076
Date:
Saturday, 22nd June 2024
Time:
10:00 AM to 2:00 PM
Documents Required
Updated Resume
Recent Increment Letter / Offer Letter with CTC break up
Latest 3 Months Pay slips & 6 Months Bank Statement
Copies of All Education Certificates
Copy of Aadhar & Pan Card
How to Apply
Interested candidates with relevant experience are encouraged to attend the walk-in interview. Please share your updated resumes to
[email protected].
[caption id="attachment_57931" align="aligncenter" width="930"] Shilpa Biologicals Hiring Midlevel R&D Biopharma Experts[/caption]
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he has always been the guy just has a beard. and i fight him all the tiime, is my enemy and i did the shop wiht him there. odd as hell. he is a winner huh. lol
dutchess meghan
and i knew her from westboro mywife snuck in but she was amy. looked like this image. different person lol. actd different and anatomically allsay nope different. and was normal did normal stuff. weas a bit of a thief, got out of it. and was a decent person to talk to like a teenage boy lol. was a tom boy but later big hair and a sluttish. but cool ok. down to earth. and said it too dont want more i am too drunk...nope. and need to study you out. and a lot of times. it was realistic life stuff and others had wierdness
Zues Hera
true too i was like that and right on hte money and needed help today and he said it the clones are here tons. and they saw it. are hienous. we sent out hi sinfor said it they have us fight. and are in our mdst and they stop them now
meghan
and you all die and thetypist
tommy f
your out tommyf. will have you hit now ok bud. bye bye fag tom
Zues Hera of course i can have it
you and your ship need a posessed capt ok lol
fine is ee. in me already and i ck cnt see it and not a computer wiz and oh boy fine
tommy f
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How to Import Medicine From India
Is it true that you are a drug merchant who needs to import great Indian medications? In the event that indeed, it is a lot of fundamental for you to know the standards and guidelines relevant in India as well as your particular country.
Each nation has separate import standards for drugs or any products so far as that is concerned. Consequently, gathering required data from various sources is in every case great.
You can look for sites on the Web for that…Read More
FDA Approval and requirements
Indian drug organizations should get endorsement for sending out the meds to a particular country. There are independent consents for every country.
Consequently, you should make sure that the organization you are bringing in medications has the fundamental endorsement in India to send out prescriptions in your country.
Because of any resistance of the pharma organization, you shouldn’t cause problems.
For instance, to trade prescriptions in Bedouin nations, the pharma organization requires GCC endorsement and the endorsement from Saudi FDA.
To trade in Lebanon or Syria; endorsement from the US FDA, EU GMP or Japanese FDA is required. To send in Bhutan, Myanmar or Vietnam, you really want ACTD Dossier and item enlistment.
Accordingly, you should realize the data prior to marking the import contract.
Other requirements
According to the Import/Commodity guidelines in India, an organization needs to get the exporter’s code number from the Save Bank of India.
Likewise, it is required to get the IEC code without that it is preposterous to expect to send prescriptions out of India. The IEC number is expected to open a ledger that is approved to bargain in unfamiliar trade.
On the off chance that you are bringing in medications from India, make sure that the pharma organization gives you the product code number and IEC code.
There are standards about giving the letter of credit and In-process quality control. These perspectives ought to be known to you in advance.
It is exceptionally easy to import meds from India assuming that you get a comprehension of the guidelines. The most ideal way is to recruit a specialist.
Top-quality medicines make India a preferred import partner
India has arisen as one of the assembling nations where merchants get the best drugs and straightforward strategies.
With the lift in the Indian economy, increasingly more pharma organizations are arising into the commodity import market for medication
M Care being the global supplier of Pharmaceutical formulation, API, KSN & intermediate products and a member of Pharmexcil are ready to provide international exposure to manufacturers for registration of their products and sales and academia for research and development. We also assist clinical research.We are exporting medicines from India to different countries like United Arab Emirates, United States, Brazil, Saudi Arabia, etc. for More Information click here…
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Culpable
Try not to think of the wounds licking
Plus all that had done still be sticking
Sing the reflection that needs kicking
After more guilt is doing much picking
With looks of disgust and start to hiss
Very obvious that who could actd piss
From a person everyone used to miss
Who was care free and filled with bliss
It sucks when there is things to remind
Which is the parts that some how bind
And thinking about seems very unkind
Or wishing that times will ever rewind
But it is no need for sorrows to drown
Making so obvious who wears a frown
Allowing everything to make so down
When people can see it all over town
No matter an inside all have to trouve
With little happiness and lots a groove
Showing that there is room to improve
Now drop any guilt and begin to move
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