ARC 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 ARC, 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.

 

We proudly offer the following regulatory services:

1. Legal agent

2. Product Assessment

3. Device Classification

4. 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

5. CMC Preparation

6. Establishment Registration and Renewal

7. 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)

8. Review label and promotional materials

9. Review drug ingredients

10. Master File Preparation (DMF, SMF, MFA and VMF)

11. USFDA Electronic Submission