Multi-Expertise: A Global Approach to Serving the Healthcare and Life Sciences Industries
In a constantly evolving sector, regulatory complexity, scientific challenges, and patient expectations demand a knowledgeable and versatile approach.
At Universal Medica Group, we’ve developed a unique multi-expertise offering combining regulatory compliance, health vigilance, training, communication, and strategic support. This synergy provides laboratories with integrated, customized, and effective solutions at every stage of their product lifecycle.
Our mission: to support you with rigor, flexibility, and innovation to ensure the quality, safety, and effectiveness of your healthcare products.
Regulatory Affairs: Ensuring the Compliance of Your Healthcare Products
In an increasingly complex regulatory landscape, Universal Medica Group supports you throughout the lifecycle of your healthcare products.
- Marketing Authorization Applications (MAA): preparation, submission, and follow-up with health authorities
- Management of MAA variations and renewals
- Compliance of labelling and package leaflets
- Regulatory support for CE marking of medical devices
- Regulatory intelligence and anticipation of industry developments
Why Choose Our Regulatory Affairs Expertise?
Our regulatory specialists help you navigate a complex environment, ensuring compliance and market access with peace of mind.
Safety Monitoring: Securing the Use of Healthcare Products
Pharmacovigilance, materiovigilance, cosmetovigilance, and nutrivigilance are key to ensuring patient safety and product compliance.
- Management of adverse events and safety cases
- Detection and analysis of risk signals
- Risk Management Plans (RMP) and Additional Risk Minimization Measures (ARMM)
- Preparation and submission of safety reports (PSUR, DSUR, PBRER, ASR, etc.)
- Audits and inspections of safety monitoring systems
Why Choose Our Safety Monitoring Expertise?
Our specialized teams ensure rigorous and proactive monitoring, maintaining compliance and safety throughout the product lifecycle.
Medical Information: Providing Reliable and Timely Access to Health Data
In a world of fast-moving information, it is essential to ensure clear and reliable scientific communication with healthcare professionals and patients.
- Multichannel management of medical information requests (phone, email, website, social media)
- Database management and interaction traceability
- Scientific support for commercial and medical teams
- Deployment of digital solutions to optimize medical information
Why Choose Our Medical Information Expertise?
We help laboratories provide accurate, well-documented responses, strengthening trust among healthcare professionals and patients.
Compliance: Ensuring Transparency and Regulatory Adherence
Adhering to transparency and ethical standards is essential to maintaining trustworthy relationships between health industries and healthcare professionals.
- Management of contracts and agreements with healthcare professionals
- Submission of transparency declarations (LEA, IDAHE 2, EPS, etc.)
- Auditing and controlling interactions with healthcare stakeholders
- Regulatory monitoring and updates to internal procedures
Why Choose Our Compliance Expertise?
Our compliance experts ensure effective and thorough adherence, mitigating risks and protecting our clients’ reputations.
Audit & Quality: Optimizing Performance and Compliance of Your Processes
Auditing is a vital tool to ensure compliance with regulatory standards and product quality throughout the manufacturing and distribution process.
- Internal and supplier audits
- Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), and Good Laboratory Practices (GLP)
- Compliance assessments against ISO, IPEC, GAMP standards, etc.
- Identification of improvement areas and corrective action planning
Why Choose Our Audit and Quality Expertise?
Our expert auditors deliver thorough, tailored assessments to streamline processes and ensure flawless compliance.
Training: Building Team Expertise
Scientific and regulatory knowledge is constantly evolving. Continuous training is essential to ensure excellence and compliance.
- Training in regulatory affairs, pharmacovigilance, medical information, and compliance
- E-learning and in-person training with Qualiopi certification
- Development of customized training modules
Why Choose Our Training Expertise?
Through Europharma and EuroAcademy, we offer tailored training paths to support skill development and mastery of industry standards.
Health Communication: Promoting Your Expertise and Products
In a competitive healthcare environment, impactful and distinctive communication is essential to engage healthcare professionals and the general public.
- Creation of scientific and marketing content
- Digital strategies and multichannel campaigns
- Events and pharmacy activations
- Promotional and educational materials for healthcare professionals
Why Choose Our Communication Expertise?
With Cherry for Life Sciences and Zebra Santé, we help laboratories boost visibility and maximize impact with key audiences.
