Our Product / Services
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Rudra marketing solutions is one of the reputed companies based in Ahmedabad (Gujarat, India) engaged in providing pharmaceutical regulatory services in India. We are supported by a team of experts who execute these services, according to the requirement of our worthy clients. We help the pharmaceutical companies stay one step ahead of regulatory changes, and upgrade their end-to-end regulatory activities. We provide services for good manufacturing practices (GMP), validation, training and documentation, drug master file (DMF), mock audits and many others, as per regulatory requirements. Widely acknowledged for efficiency, responsiveness, strategy and for being personalized, the services that we offer are one of the best in this industry. Get in touch with us to avail our pharmaceutical regulatory services at a budget-friendly price.
Some Key Facts about Our Technical Team & Working Module:
Structure
SR NO. | REGULATORY SERVICES | MARKET |
---|---|---|
1 | ADMINISTRATIVE | |
A | Procedure Management | All |
B | Communication with MOH | |
C | eCTD Conversion | |
D | Regulatory Training | |
E | USER Testing | EU |
2 | TECHNICAL | |
A |
Development Support
|
All |
B | Preparation, Compilation & Review of 2.4 & 2.5 Module ((For Generic/Hybrid/Bibliographic application) | EU |
C | Preparation, Compilation & Review of Risk Management Plan (RMP) | |
D | Review of RTR (Refuse to receive standard) as per RTR Guideline | US |
E | Review of Dossier as per ANDA Checklist | |
F | Review of BA/BE Study as per MOH Guideline | All |
G | Due Digilance of Dossier | |
3 | POST – APPROVAL | |
A | Variation Filing / Supplement Filing | EU/US |
B |
Pharmacovigilance Services
|
|
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Delivery Time : 1 Week
Advantages
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Size : Manufactured in both carbon and stainless steel Numbers 10, 10A, 11, 11P, 12, 12B/ 12D, 14, 15, 15T, 15C and 16 fit handle numbers 3, 3L, 5, 7 and 9. Numbers 18, 19, 20, 21, 22, 23, 24 and 25 fit handle numbers 4, 4L and 6 Individually V.C.I paper and foil packed. Delivered sterile as well as non sterile, in box packing of 100 piece.
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Mediplus offers a variety of protective gown, so that healthcare personnel can choose the appropriate gown for each situation. These offerings include products made with:
Why AAMI?
Details
Level | Test | Liquid Challenge | Result | Expected Barriers Effectiveness |
---|---|---|---|---|
Level 1 | ATCC 42 Impact Penetration 2 | Water | <4.5g | Minimal water resistance (some resistance to water) |
Level 2 | ATCC 42 Impact Penetration-ATCC 127 Hydrostatic Pressure3 | Water | <1.0g-<20cms | Low water resistance resistant to water spray and some resistance to water penetration under constant contact with increassing pressure) |
Level 3 | ATCC 42 Impact Penetration-ATCC 127 Hydrostatic Pressure | Water | <1-0g-50cmo | Moderate water resistant to water spray and some resistance to water penetration under constant contact with increassing pressure) |
Level 4 | ASTM F1670 Synthetic Blood Penetration Test )for surgical Drapes)-ASTM F1671 Synthetic Blood Penetration Test )for surgical Drapes)- | Surrogate Blood-Bacteriop Hages Phi-X174 | Penetration at 2 psi (13.8kpa) | Blood and viral Penetration resistance (2psi) |
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Delivery Time : 1 Week
Additional Information:
Delivery Time : 1 Week