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info@baupharma.com

Our Services

Our Services – Baupharma.

Service Provider: Pharmaceutical Companies.

We have built our services according to the experience earned during the last years on the pharmaceutical business. We link both: internal knowledge and  a network of trusted partners and collaborators that are ready to assist you overseas.  These are our main categories:

  • Regulatory Affairs:
    • Gap analysis, preparation of documentation, artwork and mockups, publishing, submission and post authorization support on EU, MENA & LATAM regions.
    • Medical translations: PL, SmPCs, Labelling and marketing material. Translators with medical and pharmaceutical background
    • Consultation with target patient groups: readability testing in all EU languages, focus test, bridging report, double bridging report, bridging statement.
  • Pharmacovigilance:
    • QPPV and deputy QPPV, Local QPPVs, PSMF, literature search and case data management for EU and MENA
    • Medical writing: writers with medical and pharmaceutical background: Environmental Risk Assessment, PSMF, Risk Management Plan, Nonclinical Overview and Summary, Clinical Overview and Summary, PSURs, DSURs, SOPs, CA/PAs.
  • Business Development and Market Access: In & Out license, Price & Reimbursement, CPP, distribution, local company representative and sales force in MENA.

Click on the corresponding subcategory from the menu bar for more information or send us an e-mail with your questions to info@baupharma.com

Our Services – Baupharma. Service Provider: Pharmaceutical Companies. Regulatory Affairs, Pharmacovigilance, Business Development. EU, MENA & LATAM.