Infarama
↗Sint-Pieters-Leeuw, Belgium
Infarama is a specialized pharmaceutical service provider based in Belgium, offering comprehensive support in Regulatory Affairs, Pharmacovigilance, and Quality Assurance. Founded in 2004, the company acts as a strategic partner for pharmaceutical and biotech companies looking to navigate the complex regulatory landscape of the Benelux (Belgium, Netherlands, Luxembourg) market.
The company provides end-to-end services including the preparation and submission of Marketing Authorization Applications (MAA), management of eCTD lifecycles, and acting as the local point of contact for national health authorities like the FAMHP (Belgium). They also offer Qualified Person (QP) and Responsible Person (RP) services, ensuring that medicinal products meet all legal and safety requirements before reaching the market.
CLASSIFICATION
Company Type:CRO
Therapeutic Areas:-
Industry:Pharmaceuticals
Sub-Industry:Regulatory & Compliance Consultancy
SIZE & FINANCIALS
Employees:1-50
Revenue:$1M-$5M
Founded:2004
Ownership:private
Status:operating
PIPELINE
Stage:Commercial
Lead Drug Stage:Approved (Service Provider)
Modalities:Small molecule, Biologics, Vaccines
Active Trials:0
Trial Phases:-
FDA Approvals:0
EMA Approvals:0
CORPORATE STRUCTURE
Key Partnerships:FAMHP (Local regulatory liaison), EMA (Regulatory submissions), Various international pharma companies (Outsourced PV/RA partner)
COMPETITION
Position:Niche Player
Competitors:QbD Group, Arithmos, Pauwels Consulting, PharmaLex, ProPharma Group
LEADERSHIP
Key Executives:
Annelies De Waele - Managing Director
Scientific Founders:Annelies De Waele
LINKS
Website:infarama.be
LinkedIn:LinkedIn Profile
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