Drug Development Consultancy & Support
Widler & Schiemann's team of subject matter experts brings 25+ years of combined experience in drug development activities, providing advice and coaching, as well as hands-on responsibility by implementing customized strategies as an integral part of your team.
Drug Development and Regulatory Strategy
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The combined knowledge across WSQMS areas of expertise can be utilized to support:
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Target Product Profile Development and Review
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Product and Clinical Development Plans
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Regulatory Affairs Services
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WSQMS global regulatory experts have 15-25 years' experience across the US, China and Europe, providing support with:
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Regulatory intelligence and expert advice on local regulatory requirements and procedures (US, EU, China)
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Advice and execution of overall regulatory strategy and submission strategy (local or global strategies)
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Health Authority interactions and Regulatory Representative (China, US and EU, Switzerland, UK, APAC)
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Licensing, registration and maintenance (DMF, IND, CTA, NDA, ANDA, BLA submissions in China, US, EU et al)
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Post-market activities
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Regulatory operation excellence model design and implementation
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GDPR representation for non-EU-based companies
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IMP Management Support
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With our experts in Investigational Medicinal Products (IMP) management, we can support your organization remotely and hands-on with the coordination and project management of:
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DP Manufacturing, packaging and labelling
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Overall supply chain logistics
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Inter-vendor communication and oversight
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Set-up of user requirement specifications for MES and IRT systems and conduction of related ‚User Acceptance Tests’
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Dedicated In-house training courses for all staff involved in IMP Supply Chain Management
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Auditing of CMOs and logistic vendors
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Overall: business process re-engineering, CMO selection and oversight
Clinical Operations Support
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WSQMS can provide consultancy on most clinical operations activities:
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Project risk management
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TMF set-up and management
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Trial management
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Vendor evaluation, selection and qualification
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Vendor Oversight Plan development
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Patient recruitment tactics
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