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Services

Regulatory Planning and Due Diligence

Scientific Advice and Protocol Assistance

Priority Medicines Initiative (PRIME) and Innovation Licensing & Access Pathway (ILAP)

Paediatric Investigation Plan (PIP)

Orphan Drug Designation

Marketing Authorization Application

Medical Writing

Target Product Profile (TPP) Development

Resources

Latest Regulatory Intelligence Roundup

Applying for Orphan Designation

Submitting Marketing Applications

Creating an effective Regulatory Plan

Agreeing a Paediatric Investigation Plan with the Paediatric Committee

Taking scientific advice and protocol assistance (PRIME and ILAP)

Glossary of Regulatory Deliverables

Articles & Webinars

Drug Development

EMA

Executive Summaries

FDA

MAA

MHRA

Oncology

Regulatory Affairs

Scientific Advice

SMEs

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office@somerville-partners.com

United Kingdom
Somerville Development Partners Ltd
2 Victoria Square, Fountain Court,
St Albans, Hertfordshire, AL1 3TF
+44 800 0209150
Company Number 14359932

Netherlands
Somerville Development Partners BV
Herengracht 420, 1017 BZ, Amsterdam
+31 20 244 6813
Company Number 88942198

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