PharmaConsult Global Pharmaceutical Consultancy and Professional Development Services
PharmaConsult Global provides professional development, training and consultancy services to pharmaceutical and medical device companies.
The company works closely with clients to develop a customised strategy in preparation for inspection audits and international regulatory submissions. Available development services include business support for legal and technical issues, regulatory affairs and compliance auditing, as well as project feasibility assessment and project management.
PharmaConsult Global’s comprehensive online training, workshops and seminars cover topics such as product development, quality management, regulatory affairs, pharmacovigilance and good practice (GxP) standards.
In addition to offices in the US and Europe, the company has more than 50 associates in the Far East, Latin America, the Middle East and North Africa (MENA) and India.
Pharmaceutical development services
PharmaConsult Global supports its clients with a broad range of regulatory and technical topics, including implementing cost-effective quality management systems (QMS), advising on legal and regulatory issues, and providing responses to regulatory inspection reports and warning letters. The company also reviews validation plans and completed studies, designs and manufactures products for a specific market, and provides facility design, validation and operation support.
PharmaConsult Global also audits business activities against international regulatory standards and GxP guidelines in regions such as the EU, the US, Canada, Australia, and Saudi Arabia.
Regulatory affairs consultancy services
PharmaConsult Global’s regulatory team establishes an efficient strategic product registration strategy. They will guide clients through the legal and regulatory requirements and ensure a clear path to market access.
The company has expertise in an array of submissions for investigational medicinal drug products.
Project feasibility assessments
PharmaConsult Global conducts feasibility studies to identify the strengths and weaknesses of a proposed business venture, including reporting on the opportunities, threats, required resources and necessary changes that should be made to avoid these issues.
PharmaConsult Global’s project management team is experienced in planning and executing development strategies for a range of projects, including new process implementation, product dossier preparation in electronic common technical document (eCTD) format, event organisation, or manufacturing site upgrades.
Each project is completed as cost-effectively as possible within a pre-arranged timeframe.
Regulatory compliance auditing
PharmaConsult Global ensures quality standards are maintained in pharmaceutical companies, preventing production delays and solving issues raised in inspection audits.
The company manages the entire regulatory inspection process to ensure procedures meet the industry’s stringent regulatory standards.
PharmaConsult Global provides high-quality on-site training courses and professional development programmes. It also organises conferences, workshops and webinars, as well as offers more than 30 eLearning courses on various topics.
The company’s approach is to identify the necessary skills, competencies and qualifications needed to perform given roles and to provide an understanding of business requirements. Guidance on functional behaviour and the implementation of a QMS are also available.
PharmaConsult Global has offered courses for the Saudi Food and Drug Administration (FDA) and the Gulf Corporation Council (GCC), as well as regulatory authorities in Bahrain, Oman and the UAE.
About PharmaConsult Global
PharmaConsult Global is registered with the European Medicines Agency (EMA) to provide regulatory affairs and pharmacovigilance services to small-medium enterprises (SME) in new innovative product development. It is also named as a preferred good clinical practice (GCP) training provider by Transcelerate Biopharma.
Products and Services
At the European Council of Ministers meeting in Sofia, Bulgaria, UK Prime Minister Theresa May made it clear that the UK will be leaving the EU Customs Union (EUCU) and as such will need to negotiate special arrangements with the European Commission (EC) for access to the European free market.Read more
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