Clinpharma
Clinpharma Group offers comprehensive consulting services in the pharmaceutical and medical device sectors, focusing on quality, safety, regulatory affairs, pharmacovigilance, market access, scientific services, and specialized training. The company is committed to providing innovative solutions, professional support, and continuous education to help clients achieve their strategic goals and succeed in the healthcare industry.
Industries
Nr. of Employees
small (1-50)
Clinpharma
Services
Consultancy covering pharmacovigilance for clinical studies and post-marketing, vigilance for devices/cosmetics/supplements, and regulatory strategy and dossier preparation for pharmaceuticals and medical devices.
Preparation and submission of price and reimbursement dossiers, market access strategy development and support during negotiations with national reimbursement authorities.
Implementation of GxP and ISO 13485 quality management systems, planning and execution of audits, and support for regulatory inspections and remediation.
Provision of medical direction, centralized medical information management and medical communications support for products.
Business consulting services including budget and forecast modelling, KPI dashboard development, marketing and sales support, and long-term access strategy development.
End-to-end project and innovation management services and interim management placements to support organizational and product development needs.
Consultancy covering pharmacovigilance for clinical studies and post-marketing, vigilance for devices/cosmetics/supplements, and regulatory strategy and dossier preparation for pharmaceuticals and medical devices.
Preparation and submission of price and reimbursement dossiers, market access strategy development and support during negotiations with national reimbursement authorities.
Implementation of GxP and ISO 13485 quality management systems, planning and execution of audits, and support for regulatory inspections and remediation.
Provision of medical direction, centralized medical information management and medical communications support for products.
Business consulting services including budget and forecast modelling, KPI dashboard development, marketing and sales support, and long-term access strategy development.
End-to-end project and innovation management services and interim management placements to support organizational and product development needs.
Expertise Areas
- Pharmacovigilance and drug safety
- Vigilance for medical devices and consumer health products
- Regulatory affairs for pharmaceuticals and medical devices
- Market access and reimbursement strategy
Key Technologies
- Electronic adverse event reporting systems
- E‑submission portals for reimbursement and regulatory dossiers
- GxP quality management frameworks
- ISO 13485 compliance frameworks
News & Updates
On April 21, 2022, EMA approved two new indications for zanubrutinib in CLL and MZL, based on clinical studies showing high response rates and safety profile.
A parliamentary inquiry requests more resources and the elimination of payback for medical devices to avoid market restrictions.
Research shows that measuring plasma levels of p-tau217 can help diagnose Alzheimer's early with high accuracy, potentially before symptoms manifest.
Amazon launches its online pharmacy service in the US, offering prescription medications with home delivery, leveraging e-commerce growth accelerated by COVID-19.
AIFA reports EMA approval of updated COVID-19 vaccines for booster doses, emphasizing their effectiveness against Omicron variants and prioritizing high-risk groups.
On April 21, 2022, EMA approved two new indications for zanubrutinib in CLL and MZL, based on clinical studies showing high response rates and safety profile.
A parliamentary inquiry requests more resources and the elimination of payback for medical devices to avoid market restrictions.
Research shows that measuring plasma levels of p-tau217 can help diagnose Alzheimer's early with high accuracy, potentially before symptoms manifest.
Amazon launches its online pharmacy service in the US, offering prescription medications with home delivery, leveraging e-commerce growth accelerated by COVID-19.
AIFA reports EMA approval of updated COVID-19 vaccines for booster doses, emphasizing their effectiveness against Omicron variants and prioritizing high-risk groups.