Pharmabide Pharmaceutical Services Clinical Research and Development Services and Pharmaceutical Market Licensing
Pharmabide Pharmaceutical Services is a consultancy firm for clinical trials, regulatory affairs, and pharmacovigilance applications.
The company provides high-quality, customised advice and solutions for a wide range of projects, including product development and training.
Pharmabide helps clients overcome business challenges within the pharmaceutical sector. Its staff are experienced in international regulatory requirements, helping clients to expand their operations to markets in the EU and worldwide.
Clinical research and development consulting services for drug development and clinical trials
Pharmabide’s clinical trials team provide advanced development in key therapeutic areas such as immunology, biotechnology, cardiovascular diseases, oncology, and neurology.
The company has an extensive clinical portfolio that includes Phase I-IV clinical trials to investigator initiated studies (IIS) and pharmacoeconomic studies. It also specialises in medical writing; study design; protocols, electronic case report form (eCRF), and informed consent form (ICF) development; investigational site selection and feasibility; regulatory package preparation; and submission to health authorities, ethics committees, and institutional review boards (IRB).
Pharmabide also offers a number of consulting, patient recruitment, clinical monitoring, project management, drug safety, statistical analysis, and quality assurance (QA) services.
Regulatory affairs consultation services
Pharmabide’s regulatory affairs team helps clients ensure their product approval dossier conforms to international regulatory requirements.
The company’s human medicines services are available for pre-submission and post-approval procedures of drug registration. This includes consultation on regulatory procedures and submission strategy; evaluation of product submission dossiers; and dossier compilation and submission to regulatory authorities for marketing applications through national procedures (MAA), mutual recognition procedures (MRP), decentralised procedures (DCP) and centralised procedure (CP) including Module 1 preparation.
The company’s staff have extensive experience in adaptation and translation of product information, including summary of product characteristics (SmPC), labelling, 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, regulatory translation, authorities interfacing, pricing, and market access.
In addition to pharmaceuticals, the company provides regulatory consultation for the medical device, cosmetics, and food supplements industries.
Pharmacovigilance services for pharmaceutical companies
Pharmabide provides pharmacovigilance services for the pharmaceutical industry, with applications in human medicines, phytovigilance, and cosmetovigilance. These activities help 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), preparation and submission of adverse events, and registering sponsor, license holders, and investigational medical products (IMP) in eudravigilance.
Pharmabide also develops clinical trial supportive documentation related to safety reporting, performance of literature searches, standards of practice (SOP) writing for pharmacovigilance, establishment of pharmacovigilance site master files (PSMF), 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 pharmacovigilance training.
Products and Services
Pharmabide and Arena International would like to cordially invite you to attend the 2018 Outsourcing in Clinical Trials Europe conference in Barcelona, Spain.Read more