s-cubed.co.uk

s-cubed.dk

Clinical Trials :: Regulatory Affairs :: S-cubed :: Pharmaceutical & Healthcare Consultancy :: Regulatory Affairs, Biometrics, Quality Assurance, QlikView and Project Management

http://www.s-cubed.dk/services/regulatory/clinical.php

Orphan Medicinal Product Designation in the EU. EU Small- and Medium-sized Enterprises (SME) Status. Regulatory Affairs « Return to Main Regulatory Affairs page. Orphan Medicinal Product Designation in the EU. EU Small- and Medium-sized Enterprises (SME) Status. What is a clinical trial? Clinical trials are classified into the following phases:. These studies enrol only a small number of people (20-80) and are designed to evaluate the safety of a drug, determine a dosage range and identify side effects.

s-cubed.dk

Additional Regulatory Activities :: Regulatory Affairs :: S-cubed :: Pharmaceutical & Healthcare Consultancy :: Regulatory Affairs, Biometrics, Quality Assurance, QlikView and Project Management

http://www.s-cubed.dk/services/regulatory/additional.php

Orphan Medicinal Product Designation in the EU. EU Small- and Medium-sized Enterprises (SME) Status. Regulatory Affairs « Return to Main Regulatory Affairs page. Orphan Medicinal Product Designation in the EU. EU Small- and Medium-sized Enterprises (SME) Status. S-cubed can provide the following additional regulatory support activities:. On-site consultancy through the placement of regulatory consultants. Review of advertising and promotional information. Publishing support for eCTDs. Review of data pack...

s-cubed.dk

CDISC Standards :: S-cubed :: Pharmaceutical & Healthcare Consultancy :: Regulatory Affairs, Biometrics, Quality Assurance, QlikView and Project Management

http://www.s-cubed.dk/services/biometrics/standards.php

Orphan Medicinal Product Designation in the EU. EU Small- and Medium-sized Enterprises (SME) Status. Expert training, advice and support for all your. As authorized trainers in CDISC. And ADaM, we provide expertise about requirements, processes, systems, and consultants experienced in implementing these standards. We have advised several major pharmaceutical companies all the way from first steps of implementing CDISC. Standards and supported more than 10 successful FDA. In Denmark, or Mark Baillet.

s-cubed.dk

Statistical Consultancy :: S-cubed :: Pharmaceutical & Healthcare Consultancy :: Regulatory Affairs, Biometrics, Quality Assurance, QlikView and Project Management

http://www.s-cubed.dk/services/biometrics/statistical.php

Orphan Medicinal Product Designation in the EU. EU Small- and Medium-sized Enterprises (SME) Status. A clear, concise and flexible service for all your statistical needs. Our Biometrics staff have expertise across the full range of statistical activities needed to progress a product through the drug development process. We have extensive experience of working with small early-stage biotech companies as well as large international pharmaceutical organisations. Preparation and attendance at agency meetings.

s-cubed.dk

Marketing Authorisation Applications :: Regulatory Affairs :: S-cubed :: Pharmaceutical & Healthcare Consultancy :: Regulatory Affairs, Biometrics, Quality Assurance, QlikView and Project Management

http://www.s-cubed.dk/services/regulatory/marketing.php

Orphan Medicinal Product Designation in the EU. EU Small- and Medium-sized Enterprises (SME) Status. Regulatory Affairs « Return to Main Regulatory Affairs page. Orphan Medicinal Product Designation in the EU. EU Small- and Medium-sized Enterprises (SME) Status. What is a Marketing Authorisation needed for? A Marketing Authorisation (MA) or ‘licence’ must first be approved. To obtain an MA, a Marketing Authorisation Application ( MAA. What does an MAA consist of? Format is applicable for all MAA. Adminis...

s-cubed.dk

SAS Programming :: S-cubed :: Pharmaceutical & Healthcare Consultancy :: Regulatory Affairs, Biometrics, Quality Assurance, QlikView and Project Management

http://www.s-cubed.dk/services/biometrics/sas_programming.php

Orphan Medicinal Product Designation in the EU. EU Small- and Medium-sized Enterprises (SME) Status. Application development, CDISC. Know-how, advice and. Support for all your SAS. S-cubed’s team of 25 statistical programming specialists has converted over 100 studies to CDISC. Standards and supported more than 10 successful FDA. Our highly experienced consultants are familiar with CDISC. Standards and all versions of SAS. Software across many platforms. For more information, contact:.

s-cubed.dk

Regulatory Submission Strategy :: Regulatory Affairs :: S-cubed :: Pharmaceutical & Healthcare Consultancy :: Regulatory Affairs, Biometrics, Quality Assurance, QlikView and Project Management

http://www.s-cubed.dk/services/regulatory/submission.php

Orphan Medicinal Product Designation in the EU. EU Small- and Medium-sized Enterprises (SME) Status. Regulatory Affairs « Return to Main Regulatory Affairs page. Orphan Medicinal Product Designation in the EU. EU Small- and Medium-sized Enterprises (SME) Status. What do you need a Marketing Authorisation for? In accordance with EU Directive 2001/83 governing medicinal products, a medicinal product can only be legally placed on the market in the European Economic Area ( EEA. According to Article 10a of Di...

s-cubed.dk

Working For Us :: S-cubed :: Pharmaceutical & Healthcare Consultancy :: Regulatory Affairs, Biometrics, Quality Assurance, QlikView and Project Management

http://www.s-cubed.dk/working.php

Orphan Medicinal Product Designation in the EU. EU Small- and Medium-sized Enterprises (SME) Status. The opportunity to join a growing team of enthusiastic. We believe that supporting our staff to achieve a satisfactory work-life balance is vital to the performance of the company as a whole, and strive to tailor each position to suit the employee’s individual requirements and personal situation. Senior Statistician ». SAS/Statistical Programmers ». We are always interested in hearing from SAS.

s-cubed.dk

Project Management :: S-cubed :: Pharmaceutical & Healthcare Consultancy :: Regulatory Affairs, Biometrics, Quality Assurance, QlikView and Project Management

http://www.s-cubed.dk/services/project.php

Orphan Medicinal Product Designation in the EU. EU Small- and Medium-sized Enterprises (SME) Status. Solid leadership, with the knowledge, competence and expertise necessary to mitigate risks and create practical solutions. Protocol writing, CRF design, site selection and management, monitoring, data collection and AE/SAE reporting. Audit preparation, coordination of audit response documents, project planning for remediation activities, management of remediation teams and progress reporting.

s-cubed.dk

Paediatric Investigation Plans :: Regulatory Affairs :: S-cubed :: Pharmaceutical & Healthcare Consultancy :: Regulatory Affairs, Biometrics, Quality Assurance, QlikView and Project Management

http://www.s-cubed.dk/services/regulatory/paediatric.php

Orphan Medicinal Product Designation in the EU. EU Small- and Medium-sized Enterprises (SME) Status. Regulatory Affairs « Return to Main Regulatory Affairs page. Orphan Medicinal Product Designation in the EU. EU Small- and Medium-sized Enterprises (SME) Status. Paediatric Medicines in the EU. Its objective is to improve the health of children in Europe by:. Facilitating the development and availability of medicines for children aged 0 to 17 years;. Ensuring that medicines for use in children are of high...