Project Description

Regulatory

After the expenditure and effort of product development, it is essential to ensure that you get the best out of your investment. Our experts will guide your regulatory strategy to help you get the most from your products in the best possible timeframe.

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 strategy. We will also prepare the registration package and manage the regulatory process.

Quality

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.

Pharmacovigilance

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 pharmacovigilance environment, under the direction of a Qualified Person for Pharmacovigilance 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 pharmacovigilance 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 pharmacovigilance 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.

Development

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 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.

Medical Information

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.

Devices & Borderline Products

We can support your project and advise you every step of the way by finding the best conformity assessment route for your product.

We can generate relevant data to populate your technical file, advise on labelling and essential information, and create a full design dossier to expedite a rapid and appropriate registration for your product(s). We work directly with Notified Bodies and Competent Authorities to meet the Directive requirements for CE-marking, granting market access into the European Union.

We are able to act as an Authorised Representative or Manufacturer in compliance with ISO 13485 and 14971 and we can support your products with a full vigilance system, as required to address the needs of your business.

We also have experience of dealing with products that fall into the medicines borderlines area, such as cosmetics and food supplements. Find out how we can help you by calling us today.

Project Management

We will designate a skilled and experienced project manager to act on your behalf, and help to produce a roadmap to success. Our bespoke service offering can provide dedicated project management for entire projects, large or small, or even for those individual, critical steps.

We will assist your business to control budgets and meet timelines, add value through the knowhow and oversight of our experienced team members, and act as a central point of contact between you and the authorities.

Training

Does your team need to learn a new skill, or are your staff due for a refresher?

Our experienced trainers deliver interactive learning, complete with workshops, course materials and examinations where required. We provide structured training modules in a range of ‘off-the-shelf’ subjects, or we can tailor a course to meet your individual requirements.

To minimise impact and find maximum value, we can offer a training package to suit you at your preferred location. Your staff will be able to complete learning objectives without incurring the cost of individual travel. Come and talk to us, to find out how we can help you.

Market Access

Knowledge of the market is a critical factor for achieving commercial success. We can analyse your portfolio and conduct evaluations of market size, segmentation and growth potential.

Using our extensive knowledge of the markets and regulatory landscape, we can help you to develop your business strategy, select partners to build your product portfolio and fill commercial gaps through in- and out-licensing activities.

We can also assist with your pharmacoeconomics and pricing/reimbursement submissions, set-up and maintenance of distribution channels and trade margin structure, and gain export certification to grant your product access to developing markets. We are able to arrange importation of products made outside the European Union and we can act as your Marketing Authorisation holder within the European Union, to help address your business needs.

We can also provide EU batch release by a Qualified Person and full pharmacovigilance services if required.

Promotion & Launch

We provide both medical and regulatory review and certification services for promotional copy through our team of registered copy approvers.

Our team has in-depth knowledge of medicines (both prescription and Over-The-Counter), medical devices, cosmetics and food supplement advertising legislation. We can review your promotional literature, advise you on campaign strategy and key messages, and obtain regulatory approval through pre-vetting where necessary.

To help you access the market, Jenson has an EU Manufacturer’s Import Authorisation and can assist with pricing and reimbursement, set-up and maintenance of distribution channels and export certification.

Due Diligence

Looking to build your portfolio? Are you planning merger and acquisition activity? Worried your dossier might contain gaps?

Our team of experienced experts can use their in-depth knowledge to evaluate facilities, data, systems and markets, ensure compliance and identify gaps and pitfalls.

Market Authorisation Holding (MAH)

Where there is a need, we can act as the Marketing Authorisation holder in the UK or European Union for your license applications or marketed products. We can also be the legal representative for clinical studies.

JensonR+ is also an SME company so can benefit from fee reductions and deferrals.

Ready to start? Let’s work together!

CONTACT US