Regulatory Affairs Services
Expert Consultants and Tailored Regulatory Support for the Life Sciences Industry
Regulatory Affairs Services
Our Regulatory Affairs Services
Strategic and operational regulatory affairs support throughout the entire development and lifecycle management of your product - from early-phase development to market and post-approval maintenance of your marketing authorization
Pharma IT’s regulatory consultants can help you navigate the complex regulatory environment for developing your pharmaceutical, medical device, drug-device combination, or cosmetic products worldwide. Our experienced team helps you integrate input from various scientific disciplines to help you ensure a strong and tailored regulatory path adapted to your target product profile.
Tailored Regulatory Support for Biotech, Medtech, and Pharma
Pharma IT’s Regulatory Affairs services cater to both small biotech firms and established pharmaceutical and medtech companies. Whether you need ad hoc regulatory expertise or long-term, specialized regulatory operational and strategic support for product development and commercialization, we are here to assist.
Strategic and operational regulatory affairs support throughout the entire development and lifecycle management of your product- from early-phase development to market and post-approval maintenance of your marketing authorization
Pharma IT’s regulatory consultants can help you navigate the complex regulatory environment for developing your pharmaceutical, medical device, drug-device combination, or cosmetic products worldwide. Our experienced team helps you integrate input from various scientific disciplines to help you ensure a strong and tailored regulatory path adapted to your target product profile.
Tailored Regulatory Support for Biotech, Medtech, and Pharma
Pharma IT’s Regulatory Affairs services cater to both small biotech firms and established pharmaceutical and medtech companies. Whether you need ad hoc regulatory expertise or long-term, specialized regulatory operational and strategic support for product development and commercialization, we are here to assist.
Regulatory Strategy and Business Support
- Regulatory strategy development
- Regulatory gap analysis
- Regulatory pathway analysis
- Regulatory classification assessment (drug, device, cosmetic, food/supplements)
- Preparation of designation requests, e.g. for orphan drug, fast-track, breakthrough disease, rare pediatric disease designation and PRIME
- Support in obtaining Health authority advice in EU & US (e.g. pre-IND, end-of-phase 2, pre-NDA/pre-BLA, Type C meetings, EMA protocol assistance/scientific advice, SME briefing meetings)
- Regulatory Intelligence on competitor products and regulatory environment
- Analysis of regulatory precedence within therapeutic area and technology
Regulatory Strategy and Business Support
- Regulatory strategy development
- Regulatory gap analysis
- Regulatory pathway analysis
- Regulatory classification assessment (drug, device, cosmetic, food/supplements)
- Preparation of designation requests, e.g. for orphan drug, fast-track, breakthrough disease, rare pediatric disease designation and PRIME
- Support in obtaining Health authority advice in EU & US (e.g. pre-IND, end-of-phase 2, pre-NDA/pre-BLA, Type C meetings, EMA protocol assistance/scientific advice, SME briefing meetings)
- Regulatory Intelligence on competitor products and regulatory environment
- Analysis of regulatory precedence within therapeutic area and technology
Regulatory Strategy and Business Support
- Regulatory strategy development
- Regulatory gap analysis
- Regulatory pathway analysis
- Regulatory classification assessment (drug, device, cosmetic, food/supplements)
- Preparation of designation requests, e.g. for orphan drug, fast-track, breakthrough disease, rare pediatric disease designation and PRIME
- Support in obtaining Health authority advice in EU & US (e.g. pre-IND, end-of-phase 2, pre-NDA/pre-BLA, Type C meetings, EMA protocol assistance/scientific advice, SME briefing meetings)
- Regulatory Intelligence on competitor products and regulatory environment
- Analysis of regulatory precedence within therapeutic area and technology
Regulatory Project Management
- Regulatory lead and project management of regulatory procedures and submissions in EU (MAA via CP, DCP/MRP, or NP) & US (IND, NDA, BLA, ANDA)
- Project management of initial submissions, geographical expansion and life cycle management
- Post-approval strategy and variation management