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Pharmabide Pharmaceutical Services

Clinical Research and Development Services and Pharmaceutical Market Licensing

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Pharmabide Pharmaceutical Services

Pharmabide Pharmaceutical Services provides guidance on pharmacovigilance (PV), clinical trials and regulatory affairs activities in the pharmaceutical industry.

Pharmabide Pharmaceutical Services provides guidance on pharmacovigilance (PV), clinical trials and regulatory affairs activities in the pharmaceutical industry.

The company offers personalised advice and addresses business challenges for a wide range of projects, including product development and training.

Pharmabide’s experienced staff have a thorough understanding of international regulatory requirements and assist clients in expanding their operations to international markets, including the EU.

Customised R&D consultation for drug developers

Pharmabide’s clinical trials team supports advanced development in key therapeutic areas such as cardiovascular diseases, oncology, immunology, biotechnology and neurology.

The company has a wide clinical portfolio that includes Phase I-IV clinical trials pharmacoeconomic studies and investigator-initiated studies (IIS). It also specialises in medical writing, informed consent form (ICF) development, study design investigational site selection and feasibility, electronic case report form (eCRF) and regulatory package preparation, as well as performing submissions to health authorities, ethics committees and institutional review boards (IRB).

Pharmabide also offers a number of project management, drug safety, consulting, patient recruitment, statistical analysis, clinical monitoring and quality assurance (QA) services.

Regulatory affairs consultation and preparation of submission dossiers

Pharmabide’s regulatory affairs team ensures product approval dossiers meet international regulatory requirements.

The company’s human medicines services are available for pre-submission and post-approval procedures of drug registration, including consultation on regulatory procedures and submission strategy, compilation and evaluation of product submission dossiers, submission to regulatory authorities for marketing applications (MAA) through national procedures, mutual recognition procedures (MRP) and decentralised procedures (DCP) and centralised procedure (CP), including Module 1 preparation.

The company’s staff are experienced in adaptation and translation of product information, including labelling, summary of product characteristics (SmPC) and product information leaflets (PIL) according to the European Medicines Agency’s Working Group on Quality Review of Documents (QRD) templates.

Regulatory support and submissions are also reviewed, as well as artwork, authorities interfacing, pricing, regulatory translation and market access.

In addition to pharmaceuticals, the company offers regulatory consultation for the medical device, cosmetics and food supplements industries.

Pharmacovigilance services for pharmaceutical companies

Pharmabide provides PV services for the pharmaceutical industry, with applications in human medicines, phytovigilance, and cosmetovigilance. These activities reduce risk and ensure the safety of drugs placed on the market.

The company procures qualified persons responsible for pharmacovigilance (QPPV) and a safety contact, which have experience in individual case safety reports (ISCR), registering sponsors, license holders, preparation and submission of adverse events, and investigational medical products (IMP) in eudravigilance.

Pharmabide also develops clinical trial supportive documentation related to safety reporting, performance of literature searches, establishment of PV site master files (PSMF), standards of practice (SOP) writing for PV, and preparation of documents such as periodic safety update reports (PSUR) and risk management plans (RMP).

In addition, the company inserts and updates entries to the European Extended EudraVigilance Medicinal Product Dictionary (XEVMPD) and offers PV training.

Contact

Pharmabide
31 Pentelis Av,
15235, Vrilissia,
Athens
Greece

Dionissia Sgoura (head of operations)
info@pharmabide.gr
+30 210 682 7177
www.pharmabide.gr

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