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Regulatory Affairs

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Services to these industries

PharmEng supports Pharmaceuticals, Biologics, Over-The-Counter (OTC), Animal Health, Radiopharmaceuticals, Clinical Trial Products, Medical Devices, Combination Products, Natural Health Products, Personal Care, Disinfectants, and Active Pharmaceutical Ingredients (API) to achieve the most cost-effective way to undertake their regulatory activities worldwide. This includes regulatory intelligence and strategy, worldwide product registration, preparation of regulatory documents, in country representation, establishment registration, and post-approval submissions.

At PharmEng, we believe sound regulatory planning is the key to success in achieving optimal time-to-market of quality products. Over the years, our experts have facilitated timely license approvals and streamlined the development process of exceptional products from start-up to post-marketing compliance for various clients.

Regulatory services:

  • Legal agent
  • Product Assessment
  • Device Classification
  • Country-specific product registration:
    • Investigation New Drug Application (IND) (Pharma, Medical Device & Animal)
    • Clinical Trial Applications (CTA) and Amendments (CTA-A) (Pharma, Medical Device & Animal)
    • New Drug Application (NDA/NDS)/Abbreviated New Drug Application (ANDA/ANDS)
    • Biologics License Application (BLA)
    • New Animal Drug Application (NADA)/ Abbreviated New Drug Application (ANDA/ANDS) & Medical Device License Application
    • Premarket Approval (PMA) Application
    • Premarket Notification (510(k))
    • New Drug Submission (NDS)/ Abbreviation New Drug Submission (ANDS)
    • DIN Application (DINA, DINB, DIND, DINF)
    • Clinical Trial Applications (CTA) and Amendments (CTA-A)
    • Medical Device License Application
  • CMC Preparation
  • Establishment Registration and Renewal
  • Prepare and Submit Post Approval Reports:
    • Regulatory inspection management
    • Regulatory intelligence
    • Post-market regulatory compliance
    • Pharmacovigilance management
    • Supplement to a New Drug Submission (SNDS)/ Supplement to Abbreviated New Drug Submission (SANDS)/ Notifiable Change/Annual Notification
    • Periodic Safety Update Report
    • Mandatory Problem Reporting, Adverse Reaction Reporting
    • Medical Device License Amendments/Fax-Back Forms
    • Yearly Biologic Product Reports (YBPR)
  • Review label and promotional materials
  • Review drug ingredients
  • Master File Preparation (DMF, SMF, MFA and VMF)
  • USFDA Electronic Submission

 

Click here to see our project locations worldwide.