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Jacobsen Pharma & MedTech Advice

E-health
Healthcare Buildings
Service&Operational
Medical Devices
Rehab
Pharmaceuticals

What we offer

Jacobsen Pharma & MedTech Advice offers a comprehensive regulatory affairs consultancy service from early product development right through to registration and beyond. As experts in pharma and medical device regulations, we guide you and help you to manage the procedures that enable your business to run smoothly and efficiently. Our staff consisting of well-educated pharmacists, chemists, veterinarians, biologists and nurses with many years of experience enable us to provide high quality services and an understanding of your products and needs. We are always up-to-date with the newest guidelines and issues regarding the regulatory affairs.

Products and solutions

Pharma- Product Development

Choice of contract manufacturer
Independent from the product formulation, we can identify contract manufacturers and be your delegate throughout formulation activities and the development of manufacturing processes and analytical procedures.

Quality assurance
We can develop or approve quality assurance systems during the manufacturing program and facilitate continuous improvement through the management of corrective and preventative actions.

Audit program and Competence development
We offer performance of Good Manufacturing Practice (GMP) compliance audits with your contract manufacturer throughout the EU and third countries. Where needed, we provide internal training within the areas of GMP. Learn more ›

Pharma- Clinical Development

A complete solution adapted to your needs
Our team of experienced specialists are ready to support your clinical trials – fully customized to your needs. We have extensive experience with:

Clinical trial applications
Investigator’s brochures
Registration with EudraVigilance
Development Safety Update Reports
ADR evaluation
Causality assessment
QPPV and deputy QPPV
Learn more ›

Pharma-Registration

Strategic regulatory consulting
We can identify regulatory requirements and possible obstacles for each stage of a product registration.

Product registration strategies
We can help you develop the best strategy and identify any pitfalls from SmPC comparison to regulatory strategy.

Registration procedures
We support you in running centralized, decentralized, mutual recognition and national procedures. Learn more ›

Pharma-Market Launch

Market access
We are specialised in getting your product on the market with as strong a foothold as possible. We have extensive experience with:

Reimbursement and price applications
Registration on commercial product databases
Launch of products
Contact to wholesalers
Management of public pharmaceutical product information databases Learn more ›

Pharma-Promotion & Advertising

Legal review of advertisements and promotion activities
When launching your product, you may also need support with the legal framework for advertisement. We can provide a legal review of your advertisements and other promotion activities for medicinal products, herbal medicines and strong vitamins/minerals.

Safety Surveillance

We offer complete and tailor-made pharmacovigilance solutions helping you to ensure that all of your pharmacovigilance requirements are fulfilled and that your systems are streamlined to the needs of your regulatory affairs.

Qualified Person for Pharmacovigilance
Pharmacovigilance System Master File
Detailed Description of Pharmacovigilance System
Risk Management System
Registration with EudraVigilance and XEVMPD
ADR/AE processing and reporting

Learn more ›

MedTech-Product development

Quality Assurance
We can perform a Gap Analysis of your existing quality system and implement a full Quality Management Document System according to ISO 13485 and FDA QSR, thereby fulfilling the requirements in The Medical Device Directives and the FDA Code of Federal Regulations. This is your guarantee of compliance when being audited.
Learn more ›

MedTech- Clinical Development

Clinical Evaluation
As required by the European Community through the Medical Device Directives, we can prepare your Clinical- and Preclinical Evaluation Reports for the Technical File.

Clinical Trial
Through partnerships, we can undertake the responsibility of Clinical Trials in all phases.

MedTech-Registration & CE Certification

To make sure that your device is suitable for the commercial market you are targeting, we can help you to clarify if the device meets the relevant definitions.

Risk Classification
Strategic regulatory consulting
CE certification

MedTech-Market Launch

CE certification and FDA Approval
We ensure your compliance to the legislative and regulatory requirements, enabling you to pass the Notified Body´s assessment of the Technical File and audit of the Quality Management System. The CE marking can now be affixed and your product effectively launched.

MedTech-Promotion & Advertising

Review of text and claiming
Helping you prepare your product launch, we can assist with translations and by reviewing text and symbols on labels, packaging material and Instructions for Use. In connection with the review, a legal assessment of your claims, promotion material and advertisements can be included.

Case stories

More than 25 years of experience

The CEO and owner Anette Jacobsen is a M.Sc.Pharm. She has more than 25 years of industrial experience within pharmaceutical R&D and regulatory affairs as well as general and technical management of generic companies in Denmark and Germany.

Contact

Anette Jacobsen
info@jacobsenadvice.com

Jacobsen Pharma & MedTech Advice

Agern Allé 24
2970 Hørsholm
jacobsenadvice.com

Find us here:

Kroatian Minister Of Health
Come see for yourself!

Ministerial delegation visit from Croatia

"I am pleased with everything I have seen and with the hospitality extended to me and my colleagues during our stay in Denmark. We are grateful to the Healthcare DENMARK team for being wonderful hosts to us and for the excellent organization of our visit."

- Dario Nakić, Croatian Minister of Health

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