Regulatory Affairs Services

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 certifications

  • CTD / 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

Clinical Trial Application:

  • Compilation of CMC, pre-clinical and clinical review for IND.

  • IND filing for US, Europe, other regulated and semi regulated markets.

  • CTA filing in various countries like Europe, US, other regulated and semi regulated markets.

Active Pharmaceutical Ingredients:

Compilation and filing of DMFs, ASMFs and CEP’s / COS.
List of Services:

  • Compilation in CTD, ACTD, eCTD publishing & Country specific Dossier

  • USFDA, Health Canada, EU and other markets Labeling

  • Marketing Applications

  • Medical Devices

  • CMC Consulting

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