Let our experts guide your regulatory affairs strategy to help you get the most from your products in the best possible timeframe. After the expenditure and effort of product development, it is essential to ensure that you get the best out of your investment.
The field of regulatory affairs encompasses all the work that is necessary to receive and maintain a marketing authorisation or registration for a medicinal product. Dossiers are at the forefront of this process. We can prepare the dossier, publish in the right format and manage the procedure from submission to close-out and our experts can assist you with the preparation of responses to questions raised by the regulatory agency. Once registration is complete, we can support you with ongoing maintenance for the registration dossier. We can also review existing dossiers for gaps and regulatory compliance
Scientific Advice Meetings with regulatory agencies can be very useful. Our team can guide you through the entire process, from making the meeting arrangements and preparing the list of questions with briefing information, through to chairing your meeting and formalising the outcome
Our regulatory specialists can assist with changes in legal status for your prescription medicine portfolio. Our experts will liaise with relevant regulatory authorities, healthcare professional and consumer-patient organisations to determine current opinion and assist in the development of the regulatory affairs strategy. We will also prepare the registration package and manage the regulatory process.
A sound quality system enhances organisation through an iterative process of continuous improvement.
We provide European Union batch release and certification by a Qualified Person, in addition to importation and retesting. We also provide Responsible Person services to support your supply chain. We conduct GMP, GCP, GVP and GLP auditing as appropriate for drug substance manufacturers, drug product manufacturers, laboratories and CROs. We also conduct GAMP auditing to ensure your automated systems and websites are compliant.
Our Technical team can review and implement quality management systems and conduct risk management assessments, and we can even act as your quality department for companies needing to outsource technical activities.
For companies with in-house teams, you can utilise our specific training and mentoring services to ensure your personnel meet the standards required by industry.
Did you know that as soon as you apply for a Marketing Authorisation, you should be conducting pharmacovigilance activities?
For both medicinal products and medical devices, we can provide a full pharmacovigilance service designed to meet the complex and changing needs of the global environment, under the direction of a Qualified Person and deputy Qualified Person for Pharmacovigilance.
We can also provide local assistance in any European Union country that requires a local QPPV. We maintain an approved pharmacovigilance system, to which we can add your product. However, if your business needs an individual system, we can design your systems and risk management plans.
We can handle your adverse event reporting and maintain your safety database. We can conduct literature searching, including local territory and languages, on your behalf, identify trends and detect signals. We also perform case assessments and audits for both marketed products and products under development. We write Periodic Safety Update Reports (PSUR), Development Safety Update Reports (DSUR) and Risk Management Plans, and we can supply medical writing services to meet your business requirements.
Strategic analysis and decision-making to support you through all stages of the pharmaceutical development process.
We will designate a skilled and experienced project manager to act on your behalf and then create a strategy specifically designed to meet the individual needs of your project. We work with, and coordinate, a series of preferred suppliers to provide outsourcing solutions, from API suppliers to manufacturers, CROs and laboratories.
Our technical specialists will advise on optimal strategy, evaluate your technical data through all stages of the pharmaceutical development process, review study protocols and conduct due diligence on your behalf. We can facilitate your clinical and non-clinical programmes through advising on strategy development and study design, and assisting with facility auditing, study conduct, management and monitoring activities.
We can develop your dosage form, optimise your manufacturing process, arrange scale-up and technology transfer, assist with the validation of the manufacturing process and analytical methods and conduct stability testing.
All holders of Marketing Authorisations in the European Union are obliged to maintain a Scientific Service to answer and collate medical and scientific enquiries from healthcare professionals.
Our experienced team can provide a dedicated, English-language scientific service for the supply and collation of medical information, with periodic trend analysis, weekly oversight reports and regular reconciliations against product safety and quality databases. We can also offer consumer enquiry services for handling patient-led enquiries about over-the-counter medicines and medical devices.
Based on the same site as our Pharmacovigilance team, we have direct access to experienced safety and medical professionals at all times, providing maximum reassurance to our clients, and leaving your customers in good hands.
A technical consultancy with a simple mission
We aim to promote better health through simplifying the journey from innovation to the marketplace.