splice regulatory solutions provides bespoke pharmaceutical, medical device and combination product regulatory consulting services, based on strong technical backgrounds in engineering, product development, and project management

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global regulatory strategy for drug-device combination products (integral, co-packaged, cross-labeled/combined use) and medical devices

 

pre-clinical, clinical, pre-market, marketing authorization, and post-market phases in US, Canada, and EU, with ROW experience

 

focus on inhalation and nasal drug delivery, with experience in intravenous/injectable routes of administration

 

subject matter expertise in combination products (21 CFR Parts 3 & 4, EU MDR & Article 117), human factors, emergency-use drug products, biocompatibility, risk management, design controls

 

Health Authority interaction, dossier authoring 

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focused on regulatory support of innovative and compliant product development, submission planning and execution, leading to safe and efficacious solutions for patients around the world