Drugs

Expertise and full range of services for small molecules

Drugs

Despite a decrease of innovative new chemical entities in the pipelines of pharmaceutical companies, we continue to work in numerous origination projects that promise to bring important treatment improvements for patients around the world.

On the other hand, many small molecules are well-known drugs with many years in the market, but they are still a major market and hold several potential opportunities, for example, drug repositioning. Many activities should be performed in a robust and efficient way, such as life cycle maintenance, registration in new markets or pharmacovigilance.

Drugs Solutions

Adhoc advice and strategic consultancy during product development Regulatory Roadmaps

Strategic regulatory and scientific assessment by providing CMC, non-clinical and clinical development plans to bring your product to the patient in the most efficient way
Feasibility assessment, including overview of development timelines and costs

Scientific Advice meetings:

Preparation of briefing packages and attendance to the meetings with authorities
National Competent Authorities (NCAs) in Europe
EMA: Scientific Advice, Protocol Assistance, Innovation Task Force (ITF)
FDA: INTERACT, Pre- BLA/NDA, PRE-IND, EOP2

Orphan Drugs Designation (ODD)

Management of ODD procedure, including pre submission
Preparation of ODD applications, including significant benefit, prevalence calculation and medical plausibility
Experience with both EMA and FDA

Pediatric Investigational Plan (PIP)

Regulatory strategy, preparation and submission management of PIP for EU and Pediatric Study Plan (PSP) for US

Regulatory Tools

Classification of your company as SME (Small Medium Enterprise)
PRIority MEdicines (PRIME) and accelerated assessment
Conditional approval
Hospital exemption

Support in Clinical Trial Application in EU (preparation and submission)

Preparation of Investigational Medicinal Product Dossier (IMPD) and Investigator’s Brochure (IB)
Clinical Trial Application (CTA) submission in EU
Ad hoc support during Clinical Trial conduction
IND Preparation and Submission

Common Technical Dossier (CTD)

Preparation of complete dossiers ready for registration procedures, including expert’s signature.
Gap analysis and update of CMC, non-clinical and clinical sections.
Technical documentation: scientific reports, PSURS, ACOs, etc.

Schedule a free meeting!

Discuss your case with our experts and receive a valuable feedback

Why Asphalion?

Asphalion’s team has extensive experience in the pharmaceutical industry and broad scientific and technical background in the areas of non-clinical, clinical and CMC. Asphalion has also experience in providing regulatory support during development and registration of chemical drugs, including generics, new chemical entities and fixed dose combinations (FCD), among others.

Lidia Cánovas

General Manager, Regulatory Affairs

“Our full range of service in Regulatory and Vigilance allows us to provide any support our clients might need. Furthermore, and what is even more important, we work with high quality standards and we are flexible to adapt our work to our clients’ schedules”

Related Resources