Abrahamsson Pharma Consulting AB
With extensive experience from the pharmaceutical industry the company provides expert support in Regulatory Affairs, Quality Assurance and Pharmacovigilance focusing mainly on pharmaceutical companies across the Nordics.
Services
The company is specialized in the pharmaceutical sector and provides high‑quality consultancy services within Regulatory Affairs, Quality Assurance, and Pharmacovigilance. These are highly regulated areas where science, clinical development and regulatory requirements intersect — demanding accurate, strategic and compliant guidance throughout the product lifecycle.
The company provides strategic and hands‑on support from development and Agency dialogue to marketing authorization and throughout the post‑approval phase.
Examples of services
- Preparation and coordination of Marketing Authorization Applications
- Preparation and management of IND/IMPD/IB documentation
- Life cycle management of authorized medicinal products
- Preparation and coordination of Scientific Advice requests and other meetings with competent authorities
- Labelling and product information development
- Support with Orphan Drug Designation applications
The comapny offer qualified QA support for both clinical development and commercial product activities.
Examples of services
- Handling of clinical trial material, including drug supply and sponsor release
- QMS development, implementation and maintenance
- Support with Deviations, CAPA, and Change Control
- Support during pre‑approval inspections and post‑inspection activities
- Interactions and coordination with Contract Manufacturers
We provide flexible and efficient PV support, particularly suitable for small and mid‑sized companies.
Examples of services
- PSMF development and maintenance
- General PV advice and interactions with competent authorities
- Post‑inspection support
Contact us
Abrahamsson Pharma Consulting AB
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