Pharmaceutical Regulatory Services

Sold By : Rudra Marketing Solutions

Product Specifications

Business TypeService Provider

Preferred Buyer From : All over the world

Product Overview

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:

Having more than 15 Years of Experience
Can provide full support from Dossier Compilation to Submission.
Stand with Client till Product Approval without any Additional Charges.
Standard Charges for each Service.
Prefer to have Tele conference with Client before proceeding ahead with any Project, for better understanding.

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 Designing of Specification Pharmaceutical development Report Review (PDR) DMF Review/ Technical pack Review Packaging material selection	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)	EU
D	Review of RTR (Refuse to receive standard) as per RTR Guideline	US
E	Review of Dossier as per ANDA Checklist	US
F	Review of BA/BE Study as per MOH Guideline	All
G	Due Digilance of Dossier	All
3	POST – APPROVAL
A	Variation Filing / Supplement Filing	EU/US
B	Pharmacovigilance Services PSUR / PABER Literature Review Aggregate Report Compilation EVMPD Database Entry

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Company Overview

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