Medical and scientific advice is a crucial element of the strategic and operational activities for the health sector companies, as the production, assessment and management of data and clinical information distinguish the whole lifecycle of medicinal and para-pharmaceutical products.
SKILLPHARMA ensures the presence of a dedicated team, technically advanced, managed to be suitable for each individual project, thus responding to the pressing regulations without neglecting the needs of flexibility and reducing business costs
Our services include:
SCIENTIFIC SERVICE
- Qualified Person on the role Scientific Service Responsible in according to legal requirements
- development and implementation of all processes needed for the scientific information activities, ensuring the compliance with the procedures and with legal requirements
- development of informative materials for internal consultation, training for staff and sales representatives
- management of the health authorities intercourse
- contact point with scientific and pharmaceutical societies, medical associations and patients
- answers to Medical Inquires from health authorities, HCP and consumers about medicinal products
- preparation, check and review of Dear Doctor Letter (DDL)
- development, review and submission of advertising and medical information material
- submission and follow-up till the end of procedure for advertising practices and medical and scientific material
- congresses, conferences and investigator meetings organization
- performing all the activities needed to obtain the authorization for scientific conferences, workshops, courses, visits to company laboratories
- cooperation with the Pharmacovigilance Unit for
– continuous monitoring of the safety profile of the drug, providing appropriate support in the evaluation of the benefit / risk ratio
– assessment of medical-scientific literature concerning medicinal products
– preparation, check and review of pharmacovigilance documentation concerning medical, scientific and epidemiological aspects (RMP; PSUR/PBRER; DSUR)
CLINICAL & NON CLINICAL ADVICE
- preparation, review and compliance monitoring of
– clinical and non-clinical documentation of medicinal products for human use and veterinary medicinal products
– all relevant technical documentation concerning medical devices, food supplements and cosmetics - products information preparation, review and update
– SMPC, PL and labelling of medicinal products for human use and veterinary medicinal
– Labelling for medical devices, biocides/PMC, foods and cosmetics - conformity assessment, health claim obtaining and variation support for non- medicinal products
- consultancy service in
– design, planning and development of clinical trials or clinical investigations
– selection of participating centers
– reviewing and monitoring of compliance of clinical protocols and clinical investigations
– preparation, revision and monitoring of compliance of the Final Report of clinical trials and clinical investigations
Packaging Leaflet User Test AND Readability Bridging Report
- QRD format preparation for SMPC, PL and leaflet
- Package information Leaflet User Test, data assessment and Report redaction
- Bridging Report Redaction to confirm the PL readability