Scendea
Scendea is an international Product Development & Regulatory Consulting Group dedicated to advancing healthcare innovation worldwide. With origins dating back over 20 years and involvement in over 1,000 development programs, Scendea offers scientific expertise and regulatory solutions to support pharmaceutical and biotechnology companies. The company focuses on reducing time-to-market and minimizing development costs through scientific excellence, industry experience, and a collaborative approach. Scendea serves a broad range of clients including pharma & biotech companies and investors, guiding products from early development to marketing approval across various therapeutic areas, with notable expertise in biologics, small molecules, and advanced therapies.
Industries
Nr. of Employees
small (1-50)
Scendea
Bishops Strotford, Hertford, United Kingdom, Europe
Services
Regulatory strategy, preparation of briefing packages, designation requests, agency meeting support and dossier compilation for IND/IMPD/NDA/BLA/MAA submissions across jurisdictions.
Clinical programme design, protocol development, end-of-phase planning, and support for clinical regulatory interactions, including CTIS/CTR and MHRA combined review submissions.
CMC strategy, formulation and stability advice, potency assay development, analytical characterisation and preparation of CMC sections for regulatory submissions.
Non-clinical programme design, toxicology strategy, animal model assessment, GLP considerations and incorporation of New Approach Methodologies into development programmes.
Support for orphan designation requests and maintenance, preparation of prevalence and medical plausibility arguments, and strategic advice on market/data/exclusivity incentives across EU/GB/US.
Advice on UK-specific regulatory requirements post-Brexit, MHRA submission routes, Innovative Licensing and Access Pathway (ILAP)/innovation passport engagement and target development profile development.
Regulatory strategy, preparation of briefing packages, designation requests, agency meeting support and dossier compilation for IND/IMPD/NDA/BLA/MAA submissions across jurisdictions.
Clinical programme design, protocol development, end-of-phase planning, and support for clinical regulatory interactions, including CTIS/CTR and MHRA combined review submissions.
CMC strategy, formulation and stability advice, potency assay development, analytical characterisation and preparation of CMC sections for regulatory submissions.
Non-clinical programme design, toxicology strategy, animal model assessment, GLP considerations and incorporation of New Approach Methodologies into development programmes.
Support for orphan designation requests and maintenance, preparation of prevalence and medical plausibility arguments, and strategic advice on market/data/exclusivity incentives across EU/GB/US.
Advice on UK-specific regulatory requirements post-Brexit, MHRA submission routes, Innovative Licensing and Access Pathway (ILAP)/innovation passport engagement and target development profile development.
Expertise Areas
- Regulatory strategy and agency engagement (FDA/EMA/MHRA)
- Clinical trial design, submissions and trial authorisation (CTR/CTIS, IRAS, MHRA combined review)
- Orphan designation and exclusivity strategy (EU/GB/US)
- CMC, formulation and scale-up for biologics and small molecules
Key Technologies
- Clinical Trials Information System (CTIS) submissions
- eCTD dossier preparation
- IRAS and MHRA combined review submission processes
- Next-generation analytical methods including mass spectrometry
News & Updates
Scendea shared their experience at the MIBio conference, a gathering of experts in biologics formulations and drug delivery, discussing biopharmaceutical stability and innovative delivery methods.
An article discussing the use of real-world data in regulatory submissions, its applications, challenges, and future outlook.
An overview of FDA’s programs to facilitate and expedite the development of drugs for serious conditions, including criteria and application processes.
Monitoring of regulatory landscape including NAMs to guide clients on incorporating new methodologies in development.
Guidance on developing potency tests for early-stage biological products, including regulatory considerations.
Scendea received the King’s Award for Enterprise for International Trade 2024, recognizing outstanding growth in international trade.
Scendea shared their experience at the MIBio conference, a gathering of experts in biologics formulations and drug delivery, discussing biopharmaceutical stability and innovative delivery methods.
An article discussing the use of real-world data in regulatory submissions, its applications, challenges, and future outlook.
An overview of FDA’s programs to facilitate and expedite the development of drugs for serious conditions, including criteria and application processes.
Monitoring of regulatory landscape including NAMs to guide clients on incorporating new methodologies in development.
Guidance on developing potency tests for early-stage biological products, including regulatory considerations.
Scendea received the King’s Award for Enterprise for International Trade 2024, recognizing outstanding growth in international trade.