Regulatory Compliance

•     Regulatory Compliance Checks
•     Gap Analyses

• Compliance audit of marketing authorisation and manufacturing documents
• Gap analysis
• Dossier updates/variation
• GMP audits

• Gap analyses of regulatory documents and dossiers
• Supplier qualification
• GMP audits

ProPharma Group GmbH is a leading consultancy and project management organisation in the fields of (bio)pharmaceutical products, medical devices, and healthcare.

Contact us in any phase of your product's lifecycle if you are looking for a partner in Product Development, Regulatory Affairs, (Pharmaco)vigilance or QA/QC. 

• RA Maintenance & Compliance
• CMC Program & Project Management

PharmaLex is a leading provider of specialized services for the pharma, biotech and medical device industries.

We guide you from early strategic planning activities and non-clinical requirements through clinical development, regulatory submission processes and post-approval / maintenance post-launch activities. Our experts use technology enabled solutions to support you through the entire product lifecycle. We deliver exceptional results — going above and beyond the standard to deliver tailor-made solutions worldwide.

The PharmaLex Group now has over 1000 employees, with 33 offices in 21 countries and more than 600 satisfied clients worldwide.

• Preparation audit inspection (incl. CAPA-management) compliance check
• Implementing risk management approaches / FMEA analyses designing, implementing and optimizing your GxP-quality system
• Quality management
• Auditing
• Gap analysis

• Assessment of regulatory compliance (between regulatory dossier and manufacturing/control documentation, e.g. Master Batch Records, test instructions)
• Regulatory CMC Management and Regulatory Change Management for active substances / drug substances and medicinal products / drug products
• Subsequent writing and updating of chemical-pharmaceutical documentation (Module 3/2.3) and further regulatory CMC documents for active substances / drug substances and medicinal products / drug products for variations/changes
• Responding to deficiency letters of competent authorities
• Special expertise in quality aspects of nasal, ophthalmic and auricular products; tablets, capsules and sterile parenterals

• Regulatory compliance checks & GAP-Analysis
• Regulatory SWOT-Analysis
• GMP/GDP-Compliance checks
• GMP/GDP-Audits & Supplier Qualification
• SOP & Working Instruction compilation
• Trainings on DRA/CMC/QM-Interface