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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

  • 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
  • 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
  • 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
  • Regulatory strategy, preparation and submission management of PIP for EU and Pediatric Study Plan (PSP) for US
  • Classification of your company as SME (Small Medium Enterprise)
  • PRIority MEdicines (PRIME) and accelerated assessment
  • Conditional approval
  • Hospital exemption
  • 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
  • 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.

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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 Canovas - Asphalion
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”

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