PharmaConsult Global's consulting services will ensure that its customers stay at the leading edge of issues affecting the pharmaceutical industry.
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.
PharmaConsult Global provides high-quality solutions to technical and regulatory issues, working with pharmaceutical and healthcare clients in Europe, the US, Latin America, the Middle East and Asia.
Regulators in both established and maturing agencies are facing challenges in their effort to provide faster access to medicines to patients that need them.
This white paper identifies some of the socio-economic factors that are influencing growth in the pharmaceutical markets by introducing issues of affordability in both developed and emerging markets and comparing these with the effects of demand to identify the markets that are likely to see high growth.
The UK Brexit secretary Dominic Raab has announced that even though the UK Government is still optimistic to explore the terms under which the UK could remain as part of the European Medicines Agency (EMA) after leaving the EU in March 2019, the possibility of no deal being reached should be considered and a contingency plan should be prepared that could take effect by 29 March 2019 to ensure that UK patients have a sufficient supply of essential medicines.
The Brexit negotiations have taken a dramatic turn this week, with the British Government rejecting the European Union’s (EU) proposals to be part of the European Economic Area (EEA) and have put forward counter-proposals that will ensure that UK can negotiate free trade arrangement with both the EU and other global markets.
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.