Service Ecosystem

(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.

(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.

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.

(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.

(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.

(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.

(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.

(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.