Service Ecosystem

Quality & Regulatory

Regulatory services and support for preclinical and pre-IND /CTA activities are provided.







Clinical Development Aspects

(i) Generation or review of a clinical development plan to support global development; (ii) Protocol development including study design, clinical endpoints, inclusion/exclusion criteria, and sample size calculation; (iii) Feasibility assessments regarding where to undertake a study based upon key selection criteria.
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Clinical Trial Associated Regulatory Activities

(i) Agency interactions including pre-CTA and pre-IND; (ii) Preparation of the core documents including protocol, IB, IMPD and IND; (iii) Submission related activities, including acting as the regulatory primary point of contact (including US agent services) and responding to agency questions.
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CMC / Quality Development Aspects

The Chemistry, manufacturing, and control (CMC) testing of drug substances play a critical role guaranteeing the quality of the drug product entering clinical trials. The main aspects of the quality development include the following activities:
- Generation or review of a CMC development plan to support global development.
- Technical CMC input including, but not limited to, manufacturing process development and validation, product characterization, assay development, control strategy and stability.
- Vendor selection and management, including technical review of manufacturing plans.
- Preparation of CMC sections of investigational new drug applications, European filings, applicable drug master files and abbreviated new drug applications.
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Drug Development Planning

(i) Generation of a Drug Development Plan (DDP) including non-clinical and clinical aspects from early-stage development up to approval; (ii) Target Product Profile (TPP) development; (iii) non-clinical and clinical development planning.
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Orphan Drug Designation (ODD)

(i) Developing an optimal strategy to support a successful ODD application; (ii) Authoring or review of ODD applications including prevalence/incidence calculation; (iii) Procedural and submission support.
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Other EU/US Specific Regulatory Activities

(i) SME applications including support in appending to Scendea’s SME status; (ii) Support relating to accelerated review applications, conditional approval, approval under exceptional circumstances; (iii) Support related to PRIME applications; (iv) Support related to RMAT designation; (v) Support related Fast Track designation, Breakthrough Therapy designation, accelerated review applications; (vi) Applications for a Rare Paediatric Disease designation/securing a priority review voucher.
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Regulatory Strategy Development

(i) Global regulatory strategy development, from early development up to approval; (ii) Identification of the legal basis for approval, and associated development planning; (iii) Identification of regulatory milestones/designations to build product value and support external funding.
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Technical / Medical / Regulatory Writing

(i) Protocol development including clinical or non-clinical/toxicology studies; (ii) Authoring of Clinical Study Reports (CSRs) and Drug Safety Update Reports (DSURs); (iii) Writing regulatory documents including: pre-IND, IND, CTA (IB and IMPD), ODD, PIP/PSP and licensing applications.
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