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 in-country 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)
- 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)
- 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
Please refer to this Regulatory Affairs Cutsheet for your reference.
