REGULATORY AFFAIRS
Medicinal Products, Medical Devices, Cosmetics and Food Supplements
Consultancy - Registrations, Variations, Renewals Applications - eCTD
he Regulatory Department of CPHS is composed of highly skilled professionals with extensive experience in the field. We offer top-quality consulting services at competitive rates, fully aligned with both European and Greek regulations and legislation. Our team is dedicated to providing reliable, tailored solutions that meet the evolving needs of our clients, ensuring compliance and regulatory success.
General Regulatory Services
Our Regulatory Department provides a broad range of consulting services designed to support companies throughout the entire product lifecycle—from development to market entry and post-marketing compliance. We assist our clients in navigating the complex regulatory landscape with efficiency, accuracy, and strategic insight.
Key general services include:
- Regulatory strategy and planning
- Preparation and submission of regulatory dossiers
- National and EU procedures support (DCP, MRP, NP)
- Regulatory intelligence and updates
- Communication and liaison with competent authorities
- Product lifecycle management and regulatory maintenance
- Development of Standard Operating Procedures (SOP) in accordance with GDPR and GXPs
- Tailored Training presentations on RA topics
Pharmaceuticals
Our Regulatory Affairs services for medicinal products cover the full lifecycle of marketing authorizations, ensuring compliance with national (EOF) and EU regulations. With deep expertise across all regulatory pathways, we provide comprehensive support to pharmaceutical companies through every stage — from development to post-marketing activities.
Our services include:
- Regulatory Strategy: Expert advice and strategic planning for optimal registration routes
- Dossier Compilation: Collection, evaluation, and scientific writing of technical documentation; full CTD dossier preparation
- Product Information Management: Preparation and translation of SmPCs, PILs, labeling, promotional content, and packaging in compliance with QRD templates and national standards
- eCTD Submissions: Preparation and management of electronic submissions
- Lifecycle Management: Coordination of initial applications, variations, renewals, MA transfers, technical transfers, and withdrawals under National, MRP, DCP, or Centralized procedures
- Pricing & HTA: Submission and support for pricing and Health Technology Assessment dossiers
- Additional Support: Ad hoc regulatory consulting, communication with authorities, and regulatory intelligence
In collaboration with our Medical Affairs department, we offer tailored regulatory and scientific support for pharmaceutical products requiring strategic depth and specialized handling.
Strategic Regulatory & Scientific Consulting
Guidance for Generics, Hybrids, Fixed Combinations, Complex Drugs, Modified-release products, Topicals, Oculars, and Well-established Use Applications, including:
- Feasibility evaluations and regulatory strategy design
- Recommendations for required studies and development plans across quality, non-clinical, and clinical areas
Bioequivalence & Pharmacokinetics
- Study design consulting for BA/BE and PK studies
- Assessment of study results and reformulation strategies
- Support for therapeutic equivalence studies
Dossier Preparation & CMC Services
- Scientific authoring (e.g., Non-Clinical/Clinical Overviews, Biowaiver documents)
- Dossier audits before acquisition or submission
- CTD conversion and upgrades
Troubleshooting & Scientific Support
- Response to deficiency letters and authority requests
- Support during EU Referral procedures
Specialized Technical Documentation
- Environmental Risk Assessments (ERA)
- Nitrosamines Risk Assessment
- Elemental Impurities Evaluation
- PDE (Permitted Daily Exposure) Reports
- Toxicological Assessments
Medical Devices
Regulatory support for all classes of medical devices (including IVDs) in accordance with MDR and IVDR:
- Technical documentation review and compilation
- Notification via EOF portal
- Translation and preparation of Labeling and promotional materials (Greek)
- Full communication with EOF
Food Supplements
Full compliance support with Greek and EU requirements:
- Dossier review and notification application submission
- Greek labeling and promotional material preparation
- Monitoring of EOF submissions and authority interactions
Cosmetics
Services aligned with Regulation (EC) 1223/2009:
- Review of product documentation for notification
- Translation and regulatory adaptation of labeling
- EOF portal submissions and authority communication
- Claims and borderline product consulting