BUILDING TRUST,
PARTNERING FOR EXCELLENCE
Our Services
MEDICINES | MEDICAL DEVICES | DIETARY SUPPLEMENTS | COSMETICS | VETERINARY PRODUCTS | BIOCIDES AND DETERGENTS
- Definition of regulatory strategies
- Contacts with Regulatory Authorities in representation of clients
- Product registration with authorities: INFARMED, DGAV, DGS, ECHA, CE-CPNP, CIAV, etc.
- Maintenance of product registrations: Changes, Renewals, and Updates
- AIM Dossier: eCTD
- CE Marking and CNP Codes
- Preparation of technical dossiers, PIFs and Safety Data Sheets (Safety Data Sheet)
- Preparation and review of labeling, package leaflet, and advertising materials
- Requests for Marketing Authorization (MA)/ Registration of Veterinary Use Products (VUP), Veterinary Use Medicines (VUM), Animal Feed Products and Animal Use Biocides (AUB)
- Requests for Exceptional Use Authorizations (EUA) and parallel import
- Requests for conducting clinical trials
- Requests for ACM: preparations or substances based on cannabis plant for medicinal purposes
MEDICINES | MEDICAL DEVICES | DIETARY SUPPLEMENTS | COSMETICS | VETERINARY PRODUCTS | BIOCIDES AND DETERGENTS
- Licensing requests (manufacturing and distribution) and process monitoring
- Audits (GMP; GDP; ISO 13485; ISO 9001)
- Implementation and review of Quality Management Systems
- Maintenance of QMS with assignment of Technical Directions (TD, RT, TR)
- Implementation of Good Manufacturing Practices (GMP/GMP)
- Implementation of Good Distribution Practices (GDP/GDP)
- Quality Manual and Procedures Manual (SOP’s)
- Risk Management Plans (ISO 14971)
- Transfers of logistics operator
MEDICINES| MEDICAL DEVICES |DIETARY SUPPLEMENTS| COSMETICS | VETERINARY PRODUCTS
- Person Responsible for Pharmacovigilance (QPPV)
- Bibliographic research in literature and issuance of research report
- Support in the implementation of the Risk Management System and Good Pharmacovigilance Practices (GVP)
- Development of Pharmacovigilance System (PSMF) and SOPs
- Periodic Safety Reports (PSR/PSUR)
- Notification of adverse reactions (CIOMs) and follow-up
- Cosmetovigilance
- Medical Device Surveillance
MEDICINES | MEDICAL DEVICES | DIETARY SUPPLEMENTS | COSMETICS | VETERINARY PRODUCTS | BIOCIDES AND DETERGENTS
- Technical and scientific opinions
- Medical Affairs (management of medical issues, interactions with healthcare professionals, compliance and transparency, etc.)
- Non-Clinical and Clinical Modules
- Pharmacoeconomic Support: Price review; reimbursements and preliminary assessment
- Readability tests and BridgingReports
- Preparation of scientific materials (promotional and non-promotional)
- Medical-scientific support during brand/product development
- Litigation, Arbitrations, and support in patents and trademarks
MEDICINES | MEDICAL DEVICES | DIETARY SUPPLEMENTS | COSMETICS | VETERINARY PRODUCTS | BIOCIDES AND DETERGENTS
- Clinical Trials
- Patents and other legal documents
- Scientific Materials and Reports
- Translations of Quality Management documentation
- Translations of labeling, package leaflets, and promotional materials
- Translation certification
MEDICINES | MEDICAL DEVICES | DIETARY SUPPLEMENTS | COSMETICS | VETERINARY PRODUCTS | BIOCIDES AND DETERGENTS
- Customized training based on specific client needs
- Development of training materials (scientific and/or commercial)
- Training of commercial teams (scientific/product)
- Good Distribution Practices
- Good Manufacturing Practices
- ISO 13485
- Regulation 745/2017 (MDR) and 746/2017 (IVDR)
- Advertising and Promotional Materials
- Regulatory Affairs
How Do We Start?
Simply request a proposal tailored to your company’s needs via info@pharegistrum.com
Consultation
Initial meeting to present your needs and the type of services you require
Strategy
We define the best strategy for your project and adapt our services to your reality
Results
One of our pharmaceutical consultants will dedicate themselves to ensuring a result that meets your expectations
