Prorelix Services Llp

Karve Nagar, Pune, Maharashtra

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Regulatory Affairs Service

Service Provider of a wide range of services which include Drug Regulatory Affairs Services.

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Drug Regulatory Affairs Services

Rs 1.5 Lakhs / PieceGet Latest Price

Mode Of ServiceOffline/Online
Payment ModeOffline/Online
License Period Time2 Week - 2 Years

Being a leader in the industry, we are engaged in providing our clients a qualitative Drug Regulatory Affairs Services. The provided service is performed by our highly experienced professionals using superior grade tools and latest technology. This service is carried out as per the variegated requirements of our valuable clients. The offered service is highly acknowledged by our clients owing to its flawlessness and hassle free execution. Moreover, clients can avail this service from us at pocket-friendly price. 

Other Details:
Prorelix research’s regulatory affairs services provide expert support in drug development programs. This is including regulatory support of clinical trials, new chemical entity’s development (NCE), marketing products, generics and medical devices.Finished Formulations:Filing of NDA / ANDAs in USA, MAs in Europe, Canada, Asia Pacific, gulf countries and Semi-regulated countries.Publishing services, compilation, verification, validation, lifecycle management of eCTD/NeeS dossier for all regulated market.Regulatory filing of dosage forms including Immediate/ Modified released solid dosage forms, parenterals (liquid, powder for injection), Nasal spray etc.ANDA/ Generic Application with Paragraph I, II, III and IV certificationsCTD / eCTD submissions with MRPs & DCP procedures in Europe.Post approval maintenance – submission of PAS, CBE 30/CBE, Annual Reports to US, Variations to EU.Drug listing and SPL support for labeling for US.PIL and labeling support for other countries.Dossier compilation, submissions as per country specific norms for ROW market

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Prorelix Services LlpNo. 102 A/B, 1st Floor, Survey No-53, CTS No-290, Park Plaza, Karve Nagar, Pune-411052, Maharashtra, India

Niranjan Andhalkar (Owner)

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