Clinical development stage

1)    Regulatory roadmap oriented towards future product commercialization:

• Strategic regulatory and scientific assessment by providing advice on preclinical requirements, CMC aspects and  clinical development plans to bring your product to the patient in the most efficient way.
• Regulatory gap analysis at all stages of development.
• Feasibility assessment, including overview of clinical development plans, timelines and costs

2)    Strategic consultancy throughout the clinical development plan.

• Advise on data selection, evidence and endpoints to be presented to comply with proposed objectives, as well as support in target population definition.
• Selection of study adequacy to ensure optimal regulatory strategy and data presentation.
• Costs and timelines management.
• Advise on study protocol definition from regulatory perspective.

3)    Regulatory Tools

• Classification of your company as SME (Small Medium Enterprise), with the waivers and facilities this involves.
• Strategy search for fast-track regulatory accelerated assessment tools: PRIority Medicines (PRIME) programme; accelerated assessment, future conditional approval, compassionate use, etc.
• Potential waivers definition.

4)    Support in Scientific Advice meetings with regulatory authorities, including strategic and operative support in the meeting. Preparation of Briefing Package, attendance to meetings with authorities and adequation of the meeting content to comply with company plans.

• Meetings with National Competent Authorities (NCAs) in Europe.
• EMA: Scientific advice meetings (contextualized for each product), protocol Assistance, Innovation Task Force (ITF)
• FDA meetings in multidisciplinary or CMC-based focus with Asphalion US expert partner: Type A (clinical holds and dispute intermediation), Type B (Pre-IND, EOP2 meetings) and Type C meetings.

5)    Medical writing services for clinical and non-clinical evidence generation, including:

• IMPD (Investigational Medicinal Product Dossier) and IB (Investigator’s Brochure) generation and update.
• Investigational New Drug applications (IND) in US.

6)  Support in clinical trial applications and submissions in EU/FDA:

• Clinical Trial Application (CTA), also those based on the new Regulation by CTIS in EU.
• Investigational New Drug applications (IND) preparation and submission in US.
• Clinical Trial Application in UK.

7)    Paediatric Investigational Plan (PIP)

• Regulatory strategy, preparation and submission management of Paediatric Investigational Plan (PIP) for EU and Pediatric Study Plan (PSP) for US
• UK PIPs.

8)    Management of Orphan Drug Designation (ODD) procedure in EU and US:

• Pre-submission of ODD.
• Preparation of ODD applications including: significant benefit, prevalence calculation and medical plausibility.

9)    Pre-approval development support in UK market application and entity requirements:

• National Scientific Advice with MHRA
• UK Orphan Drug Designation Application
• UK PIP
• Clinical Trial Application