Regulatory
Affairs
Ensuring compliance across the full product lifecycle
The Challenge We Address
Life Science companies operate in a landscape where regulations evolve faster than ever and vary widely across geographies.
Pharmaceutical, biotechnology, medical-device, in-vitro diagnostics and cosmetics companies must gain and sustain market authorisations across multiple jurisdictions while controlling time-to-market, supply-chain resilience, manufacturing and cost of compliance.
Every new guideline – from EU Regulations 2017/745-746 to evolving FDA, ICH and MDSAP requirements – demands swift assimilation into quality systems, technical files, and clinical programmes.
Active regulatory monitoring, coupled with strict quality control, is essential to ensure compliance with local and international requirements.
Post-approval, regulatory obligations remain stringent: manufacturers are required to detect and manage safety signals, maintain robust post-market surveillance, and defend the benefit–risk balance of their products throughout the lifecycle.
Our Regulatory Affairs Approach
Efor acts as a strategic partner committed to ensuring the continuous compliance of your registrations and products.
By adopting a risk-based approach, we map global regulatory trends, assess risk and opportunity, and design pragmatic pathways that align your scientific innovations with global authorities’ expectations.
Robust governance, transparent communication, and flawless documentation enable us to deliver fully compliant dossiers, seamless inspection readiness, and the confidence you need to fast-track your innovations.
Our Regulatory Affairs Services
Our experts support you at every stage of your healthcare product’s lifecycle. Whether it’s a comprehensive project mandate, dedicated on-site integration with your teams, turnkey deliverables, or flexible, on-demand guidance via our hotline, we adapt to best serve your needs:
Medicines & Pharmaceutical Products
- Development of regulatory strategy
- Gap analyses
- CTD/ACTD authoring
- Initial and variation submissions (EU/export)
- MA transfers
- Creation or update of Site Master Files (SMF)
- Promotional-material approval
Medical Devices (MD) & In Vitro Diagnostics (IVD)
- Market-access strategy (EU/USA)
- Design and development (ISO 13485)
- Technical documentation for CE marking under MDR 2017/745 and IVDR 2017/746, plus 510(k)/De Novo/PMA files in the USA
- Risk management (ISO 14971)
- Usability engineering (IEC 62366)
- UDI & Eudamed
- Promotional materials
- Post-market surveillance (PMS)
Clinical Affairs & Market Access
- Full-service clinical CRO
- Clinical evaluation (MD) and performance evaluation (IVD)—CER/PER, PMCF/PMPF, SSCP
- Medical and scientific writing (publications, state-of-the-art reviews)
- Reimbursement dossiers (France)
- CTD Module 5
Biological Risk, Biocompatibility & Toxicology
- Biological evaluation (BRA/BER) per ISO 10993
- Toxicological risk assessment (TRA)
- Test plans and lab oversight
- Validation of sterilization, cleaning, packaging, transport, and reprocessing
- PDE & impurity calculations (ICH Q3A-E)
- Nitrosamines and ADME-tox profiles
- CTD Module 4 authoring
- Extractables & leachables (E&L)
Post-Market Surveillance (PMS) & Vigilance
- PMS plans and reports
- PSUR/DSUR
- Signal detection and trend analysis
- Vigilance case management
- Pharmacovigilance System Master File (PSMF) authoring
Regulatory Affairs Training
Our accredited training center also offers programs covering all these applications and areas of expertise to strengthen your teams’ regulatory capabilities.
Why Choose Efor?
Partnering with Efor gives you direct access to an international team of seasoned regulatory affairs specialists, engineers, auditors, and trainers specialized in the therapeutic areas you target.
Our multidisciplinary experts from diverse professions and industries pool their know-how across the entire product lifecycle: defining robust strategies, establishing and controlling inspection-ready quality systems, and securing rapid market authorizations.
By combining strategic vision, operational rigor, and on-the-ground presence, we minimize risk and protect your commercial objectives.
Outcomes for Our Clients
By entrusting us with your regulatory, clinical, and quality challenges, your teams can devote their energy to innovation and growth:
- Obtain approvals sooner and reach international markets faster
- Maintain lasting compliance and be fully prepared for inspections
- Minimize risk and protect patient safety with continuous post-market vigilance
- Elevate your teams’ capabilities through tailor-made, product-focused training
Interested in discovering how our integrated expertise can supercharge your next project?
Contact us today and let’s tackle your next challenge together.
Our trainings
Our on-site trainers skillfully and pragmatically enhance our clients’ expertise in accordance with technical, regulatory, and quality challenges, while making the learning process enjoyable.
Our business fields
Our specialists offer tailored solutions in the field of Life Sciences and Global Industries.
Join the adventure
More than just a resume, we are looking for personalities. Reveal your talent at Efor.
