REGULATORY AFFAIRS

Inpharmatis offers comprehensive regulatory affairs services to Life Science Industry including Drug Development and Vigilance Services to pharmaceutical, medical device, food supplements, cosmetic and biotech companies.

Our area of expertise lies in the European & CIS market, however though our network of credible partners we are able to manage also US, Latin America and selected RoW procedures.

A multi-disciplinary team of qualified regulatory affairs consultants is at your disposal for all aspects of your marketing authorisation applications for active substances and human medicinal products. Inpharmatis shall provide full regulatory support over the whole life cycle of your product.

Advise on regulatory submission strategy

• Active Pharmaceutical Ingredients
  – ASMF development
  – FDA & EDQM lodgment services
• Finished Medicinal Products
  –  Biologicals
  – Biosimilar
  – Biotech products and advance therapies
  – Orphan drug products
  – NCEs
  – Generics, bibliographical and herbals

Development of regulatory strategy for the product’s life cycle

• Consideration of international regulatory requirements
• Regulatory classification of products across different jurisdictions
• Provide expert regulatory CMC compliance advice throughout development
• Work with Sponsors and regulatory authorities through the resolution of complex development issues
• Act as an EU Agent in Europe, Nominated Local Representative for CIS submissions
• Assist with due diligence activities for investors/licensees
• Assistance in establishing necessary systems for market entry
  – Registration of legal entities for marketing authorisation applicants
  – GMP consulting and organization of inspections
  – Batch release and testing arrangements
  – Services of Qualified Person
  – Pharmacovigilance Systems & Services of QPPV
  – Government Access Consulting
• Revision of plans in accordance to the changed guidelines
• Development of SOPs & Management Systems

Submission preparation / review, filing and management

• Submission preparation and management throughout the whole pre-approval procedure
• Pre-submission meetings
• Post-approval submission management (preparation & filing variations, line extensions, renewals, re-classification submissions, PSURs and RMPs)
• Labelling management
• Scientific and Medical Writing Services
• Reimbursement applications and management
• Local representation
• eSubmission Services

Regulatory Strategy Consulting

• Classification of your product (portfolio) according to national requirements (Class I, IIa, IIb, III)
• Filing strategy in different markets, clinical trial requirements
• Development of the technical documentation
• Risk assessment
• Guidance on conformity assessment procedure
• Medicinal products with medical device components

Filing and product life cycle management

• Establishing and running vigilance systems
• Local safety officer services
• European / CIS representative services
• SOPs writing
• Training services

Cosmetic Products

• Product classification (including borderline products)
• Product labeling in different languages and labelling management
• Development of Product Information File
• Safety Assessment
• Function of Responsible Person in EU and Local Representative in CIS
• Notification in the EU CPNP system
• Registrations in CIS
• Full Cosmetovigilance services

PHARMACOVIGILANCE

Entrust your pharmacovigilance concerns in the experienced hands of our Team. Whether you need an urgent solution for an unexpected problem or are seeking to outsource entire pharmacovigilance processes – our knowledgeable consultants will be there for you.

• Services of EU QPPV, Local QPPV
• Pharmacovilgilance System Set up and Review services
• ICSR management
• On-going monitoring and signal management
• Literature surveillance services
• Risk management
• Reporting
  – Product Safety Update Reports (PSURs)
  – Periodic Benefit-Risk Evaluation Reports (PBRERs)
  – Development Safety Update Reports (DSURs)
  – Periodic Adverse Drug Experience Reports (PADERs)
  – Risk Management Reports (RMPs)
• Safety Data Exchange Agreements
• Pharmacovigilance Quality System, audits and inspections
  – Pharmacovigilance System Master File (PSMF)
  – Standard Operating Procedures (SOPs)
  – Internal and third party audits, mock-up inspections, CAPA writing
• Training