Regulatory Affairs

We provide solutions to meet both local and global regulatory requirements in the most cost-effective manner.

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 ApplicationPremarket Approval (PMA) 

- ApplicationPremarket 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