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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 Stategy
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Drug Development and Regulatory Strategy

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  • The combined knowledge across WSQMS areas of expertise can be utilized to support:

    • Target Product Profile Development and Review

    • Product and Clinical Development Plans

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: 

    • Regulatory intelligence and expert advice on local regulatory requirements and procedures (US, EU, China)

    • Advice and execution of overall regulatory strategy and submission strategy (local or global strategies)

    • Health Authority interactions and Regulatory Representative (China, US and EU, Switzerland, UK, APAC)

    • Licensing, registration and maintenance (DMF, IND, CTA, NDA, ANDA, BLA submissions in China, US, EU et al)

    • Post-market activities

    • Regulatory operation excellence model design and implementation

    • 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:

    • DP Manufacturing, packaging and labelling

    • Overall supply chain logistics

    • Inter-vendor communication and oversight

    • Set-up of user requirement specifications for MES and IRT systems and conduction of related ‚User Acceptance Tests’

    • Dedicated In-house training courses for all staff involved in IMP Supply Chain Management

    • Auditing of CMOs and logistic vendors

  • 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:

    • Project risk management

    • TMF set-up and management

    • Trial management

    • Vendor evaluation, selection and qualification

    • Vendor Oversight Plan development

    • Patient recruitment tactics

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