Regulatory Affairs Services
Expert Consultants and Tailored Regulatory Support for the Life Sciences Industry
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 Affairs Services
Our Regulatory Affairs Services
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
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
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
Regulatory Operational Support
- Compilation, writing, review and submission of regulatory documentation e.g. IMPD, IND, CTA, PIP, iPSP
- Handling of HQ / Affiliate RA tasks
- Local regulatory representation and support in the Nordics (e.g. translations, artwork, compliance with local requirements)
- eCTD Publishing
- Implementation and upgrades of publishing tools
- Guidance on eSubmission readiness of documents
Regulatory Operational Support
- Compilation, writing, review and submission of regulatory documentation e.g. IMPD, IND, CTA, PIP, iPSP
- Handling of HQ / Affiliate RA tasks
- Local regulatory representation and support in the Nordics (e.g. translations, artwork, compliance with local requirements)
- eCTD Publishing
- Implementation and upgrades of publishing tools
- Guidance on eSubmission readiness of documents
Regulatory Operational Support
- Compilation, writing, review and submission of regulatory documentation e.g. IMPD, IND, CTA, PIP, iPSP
- Handling of HQ / Affiliate RA tasks
- Local regulatory representation and support in the Nordics (e.g. translations, artwork, compliance with local requirements)
- eCTD Publishing
- Implementation and upgrades of publishing tools
- Guidance on eSubmission readiness of documents
Looking for help with something not listed above? Don't hesitate to reach out.
Our team can also provide cross-functional support across other departments
Looking for help with something not listed above? Don't hesitate to reach out.
Our team can also provide cross-functional support across other departments
We can provide comprehensive regulatory support through Pharma IT and the PLG network
As part of the Pharma IT one-stop consultancy shop, we provide high-quality Regulatory Affairs support in a cross-functional manner, seamlessly involving other Pharma IT competences and services. Additionally, being part of the ProductLife Group (PLG) network gives us direct access to a vast array of specialized skills across various industries and markets worldwide. This allows us to build strong consultancy teams tailored to meet the specific needs of our customers.
Anne Louise Kirkegaard, Director of Regulatory Affairs Services