Regions  
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Your Innovative Regulatory Partner

Our aim is to offer companies of all sizes a tailored, quality, adaptable and compliant solutions to their regulatory needs that is cost-conscious.

We are a group of professionals who have years of combined experience in many aspects of regulatory affairs. Our span of experience ensures that we are able to manage, advise and educate on regulatory affairs for the majority of functions within Pharmaceutical industry.

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Our Vision

We want to be one of the most reputable providers of regulatory services and solutions.

We want to be a committed, professional and innovative regulatory services and solutions partner in delivering treatments to patients faster around the world. Our approach is to do the right thing and in the right way which is compliant with the highest ethical and regulatory standards.

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Regulatory Resourcing Services

We have an established network of Regulatory experts around the world. Our Resourcing models help to place those experts for short or long term requirements of the clients for timely, efficient and cost-effective delivery of projects.

Our span of experience ensures that we are able to manage, advise and educate on regulatory affairs for the majority of functions within Pharmaceutical industry.

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Trusted by Innovators

Our regulatory expert consultants are trusted by innovative pharma and biotech companies.

About us

XP FORTE is a professional regulatory services provider. We design services
carefully around the needs of our clients to global standards with a dedicated
team of experts.

Explore our services

We Put Your Needs First!

  • Scientific Advice
  • Paediatric Investigation Plans
  • Orphan Designations
  • Community Referrals
  • Clinical and non­clinical overviews and summaries
  • Early access medicines/compassionate use programmes
  • Regulatory/Medical Writing
  • Paediatric Investigation Development Plans -PIP/PSP
  • Orphan/Rare Disease Designations
  • IVDR/cDX
  • EU-CTR
  • Special Protocol Assistance
  • CTA/IND
  • MAA/NDA/BLA
  • MHRA Innovative Passport
  • Post Approval/Life Cycle Management
  • Label and Safety Updates
  • Quality/RegCMC
  • Regulatory Writing and Reviews (Protocols, IBs and ICFs)
  • Clinical and Non¬clinical Overviews and Summaries
  • Early Access Medicines/Compassionate Use programmes
  • Clinical Trial Disclosure/Transparency
  • Redaction Services
  • Community Referrals

Orphan Designations

Paediatric Investigation Plans (PIPs)

Centralised

Decentralised

Mutual Recognition procedures

  • CHMP, PRAC and CMD(h) referrals
  • Small, Medium Enterprise (SME) status
  • Scientific advice
  • Clinical trial applications
  • Orphan Designations
  • Paediatric Investigation Plans (PIPs)
  • Centralised
  • Decentralised
  • Mutual Recognition procedures
  • Orphan Designations
  • Paediatric Investigation Plans (PIPs)
  • Clinical Trial or Investigational New Drug Applications – CTA/IND
  • Invitro/CDX
  • Marketing Authorisation or New Drug Applications – MAA/(s)NDA/(s)BLA/ANDA
  • Biosimilar Submissions
  • EU Centralised, Decentralised, Mutual Recognition Procedures
  • EU CHMP, PRAC and CMD(h) Referrals
  • EU Small, Medium Enterprise (SME) Status
  • Scientific Advice or Pre-Phase III Health Authority Interactions
  • Label/Safety Updates
  • Marketing Authorisation/License Renewals
  • Investigator Brochures
  • Clinical Trials Protocols
  • Clinical Study Reports
  • PSURs, PBRERS
  • NICE and reimbursement support documents
  • SmPC and PIL labelling reviews
  • Health Authority/Scientific Advice
  • Expert Advisory Committee Reviews
  • Patient Groups
  • Investigator Brochures
  • Clinical Trials Protocols
  • Clinical Study Reports
  • PSUR/PBER
  • RMP
  • SmPC and PIL labelling reviews
  • Reimbursement Support Documents eg NICE and other Payer Groups
  • Patient Advocacy
  • EU Regulatory Strategy
  • Clinical Trial Application – EU CTR
  • Medical Writing for Protocols
  • Scientific Advice and Pre submission Meetings
  • Marketing Authorisation Applications
  • Post Marketing and Lifecycle Management
  • Paediatric Applications
  • Orphan Drug Designations
  • EU Regulatory Strategy
  • Clinical Trial Application – EU CTR
  • CTIS (Part 1 and Part 2 documents)
  • IVDR Applications
  • Medical Writing for Protocols
  • Scientific Advice and Pre submission Meetings
  • Marketing Authorisation Applications
  • Post Approval and Lifecycle Management
  • Variations including quality and extension of indications
  • Paediatric Applications
  • Orphan Drug Designations
  • Scientific Advice
  • Paediatric Investigation Plans
  • Orphan Designations
  • Community Referrals
  • Clinical and non­clinical overviews and summaries
  • Early access medicines/compassionate use programmes
  • UK Regulatory Strategy
  • Clinical Development
  • Innovation Passport
  • Marketing Authorisations
  • Post Authorisation and Life Cycle Management
  • Paediatrics
  • Orphan Designation
  • MHRA Gateway/ICSR submissions
  • Scientific Advice
  • Paediatric Investigation Plans
  • Orphan Designations
  • Community Referrals
  • Clinical and non­clinical overviews and summaries
  • Early access medicines/compassionate use programmes
  • US Regulatory Strategy
  • FDA meetings
  • IND Submissions
  • (s)NDA and (s)BLA Submissions
  • PMA Submissions
  • Post Marketing Commitment (PMC) Submissions
  • Paediatric Study Plans
  • ACCELERATE/Molecular Target List
  • Rare Disease/Special Protocol Assistance
  • EU Regulatory Strategy
  • Clinical Trial Application – EU CTR
  • Medical Writing for Protocols
  • Scientific Advice and Pre submission Meetings
  • Marketing Authorisation Applications
  • Post Marketing and Lifecycle Management
  • Paediatric Applications
  • Orphan Drug Designations
  • NMPA Meetings & Submissions
  • INDs and NDAs
  • EU Regulatory Strategy
  • Clinical Trial Application – EU CTR
  • Medical Writing for Protocols
  • Scientific Advice and Pre submission Meetings
  • Marketing Authorisation Applications
  • Post Marketing and Lifecycle Management
  • Paediatric Applications
  • Orphan Drug Designations
  • CDSCO Submissions INDs and NDAs
  • EU Regulatory Strategy
  • Clinical Trial Application – EU CTR
  • Medical Writing for Protocols
  • Scientific Advice and Pre submission Meetings
  • Marketing Authorisation Applications
  • Post Marketing and Lifecycle Management
  • Paediatric Applications
  • Orphan Drug Designations
  • PMDA Meetings & Submissions
  • Strategy of SAKIGAKE
  • EU Regulatory Strategy
  • Clinical Trial Application – EU CTR
  • Medical Writing for Protocols
  • Scientific Advice and Pre submission Meetings
  • Marketing Authorisation Applications
  • Post Marketing and Lifecycle Management
  • Paediatric Applications
  • Orphan Drug Designations
  • Global Regulatory Strategy
  • Orphan designations
  • Regulatory Operations
  • Regulatory Publishing
  • Biostatistics
  • Pharmacovigilance and Safety
  • Document Management
  • Regulatory Writing and Review
  • Regional Regulatory requirements
  • SOP generation
  • Literature Searches
  • EU Regulatory Strategy
  • Clinical Trial Application – EU CTR
  • Medical Writing for Protocols
  • Scientific Advice and Pre submission Meetings
  • Marketing Authorisation Applications
  • Post Marketing and Lifecycle Management
  • Paediatric Applications
  • Orphan Drug Designations
  • Regional Regulatory Strategist (EU, US, UK, Japan, China, India and Global)
  • Submission Manager
  • Regulatory Operations Manager
  • Regulatory Project Manager
  • Regulatory Associate

Our Team

XP Forte has a team of experts ready to provide support and advice for any questions or special requests you may have, so feel free to give us a call if you are in need.

Regulatory Resourcing Services

XP FORTE networks with global regulatory affairs experts for the strategic regulatory resourcing needs of our drug development partners around the world. Our friendly network of experts also ready to help our partners with their various regulatory demands.

Regulatory Strategy Experts

Regulatory strategy experts provide their  advise on global and regional drug development. We can devise strategy and manage all aspects of the regulatory functions including document creation for all the major regions including US , EU, Japan and China.

Domain Experts

Our domain experts in Regulatory Project Management, Submissions and Operations add value and timely support to the regulatory functions for smooth sailing of the end-to-end regulatory project and submission delivery.

Consultation

Our experts provide consultation on specific aspects of Regulatory affairs such as scientific advice/FDA consultations.

EU Strategy Experts

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EU Strategy Experts

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Client Reviews

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Had a great initial interaction with XPFORTE to explore the offerings. This is an exciting group of people who are very much into Regulatory Affairs with an in-depth understanding of Drug Development. Their zeal to contribute to bringing the treatments faster is evident with their curious and innovation-oriented mindset, and we are further looking to work with them.

VC-backed Biotech

VP

I am one of the regulatory experts with experience in strategic US Regulatory Affairs and had an opportunity to work with XP FORTE. This is an exciting place to work with a talented group of professionals. I highly recommend this group for any global regulatory affairs resourcing needs

Regulatory Consultant

US

In a fast-changing world, keeping up with the regulatory landscape is important for us as biotech innovators with a portfolio of promising assets. Knowing that XP FORTE can offer its expertise helped us to align our priorities.

Business Development

Biotech

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We need a strategy for bringing our new treatment paradigm to US patients. XP Forte quickly responded to our request and put together a plan for regulatory interactions. We are happy to work further with this highly specialised regulatory group.

Pharma Company

Director

Xpforte helped our company with a successful paediatric application in the EU They always have been resourceful in helping with our paediatric regulatory plans in terms of strategy and execution for a successful outcome.

Caleb Paul

Company CEO

Xpforte helped our company with a successful paediatric application in the EU They always have been resourceful in helping with our paediatric regulatory plans in terms of strategy and execution for a successful outcome.

Caleb Paul

Company CEO

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Had a great initial interaction with XPFORTE to explore the offerings. This is an exciting group of people who are very much into Regulatory Affairs with an in-depth understanding of Drug Development. Their zeal to contribute to bringing the treatments faster is evident with their curious and innovation-oriented mindset, and we are further looking to work with them.

VC-backed Biotech

VP

I am one of the regulatory experts with experience in strategic US Regulatory Affairs and had an opportunity to work with XP FORTE. This is an exciting place to work with a talented group of professionals. I highly recommend this group for any global regulatory affairs resourcing needs

Regulatory Consultant

US

In a fast-changing world, keeping up with the regulatory landscape is important for us as biotech innovators with a portfolio of promising assets. Knowing that XP FORTE can offer its expertise helped us to align our priorities.

Business Development

Biotech

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Connect with us

We are committed to exceeding your needs. Questions, comments or special
requests? We’d love to hear from you, so don’t hesitate to reach out today.

Phone No:  44 (0) 757 0343 042

Address:  London, United Kingdom

Email:  support@xpforte.com

Link: XP Forte Regulatory Limited: Overview | LinkedIn