Services

ASPHALION offers comprehensive services for Drug Development and Regulatory Affairs, include all phases ranging from integrated development plans for innovative emergent companies till routine maintenance work for long-registered products.

Regulatory Support during Development

• Feasibility assessments by our team of experts
• Roadmaps: Non-clinical and clinical development plans, including timelines and cost forecasts
• Scientific advice: Expertise for optimal outcome with EMA, EU-NCAs, FDA
• Orphan drug designations: EMA and FDA

Notable achievements:

• Implemented regulatory roadmaps and feasibility assessments for
• New chemical entities, innovative vaccine therapy, cell therapy, chimeric antibodies, biological drug manufacturing, gene therapy
• IMPDs, IBs, CTAs, and INDs (FDA) in a wide range of therapeutic areas
• Scientific Advice procedures with EMA, MHRA, CbG, MPA, BfArM, PEI, AFSSAPS, AEMPS
• Preparation of briefing package, LoQs, strategy, presentation and back-up slides, rehearsals, direct support for meeting
• Successful Paediatric Investigation Plans
• PIPs, Waivers, Deferrals, PUMAs, Art. 45/46

ATMPs / BIOTECH

• SA procedures with EMA and AEMPS
• Pre-submission meetings with EMA and MHRA
• Complete dossier compilation in gastroenterology indication
• Successful PIP procedure in gastroenterology indication
• IMPD preparation in tissue regeneration
• Successful management of interactions with authorities (LoI, eligibility, SME, ODD)

Regulatory Strategy

• EU procedures (CP, DCP, MRP, NP) – minimum time-to-market and maximum cost efficiency
• Company and Dossier Due Diligences
• Global roll-outs including emerging markets and direct FDA insight via US agent
• Medical device classification strategy

Notable achievements:

• Broad experience with EU procedures
• Assessment of EU procedures: time-to-market, risks and opportunities
• Definition of international regulatory strategy / global roll-outs
• Company and dossier due diligence
• Validation of project plans with Regulatory Authorities
• Strategies for patent protection
• Build-up of technical dossiers for fundraising

Medical Devices

• Successful classification proposal
• Compilation of technical files
• Conformity assessments
• Notified body search
• Preparation of plant master files
• Review of quality systems
• Risk analysis
• Our experience includes
• TÜV NORD CERT GmbH, Class IIa Medical Device assessed by BSI, In vitro Diagnostic DNA Microarray Device, Class IIa and IIb Medical Devices assessed by SGS UK Ltd.

Writing and Authoring

• Registration dossiers for all types of products
• Gap analysis and update of clinical, non-clinical and quality documentation
• Technical documentation – such as IMPD, IB, CTA, SA briefing packages, ODD applications, and more

Notable achievements:

• M2.4 / 2.5
• Generic in DCP/MRP procedures (15-20 CMSs)
• M2.4 / 2.6 and M2.5 / 2.7
• Bibliographic dossiers
• M2.5 / 2.7 / SPC / PIL
• ATMP centralised application
• Combination product (cardiovascular) centralised application
• CMC modules 2.3 / 3 / ASMF / DMF
• Biological product (oncology) centralised application
• Environmental Risk Assessment (ERA)
• NCEs and generics in centralised, DCP and MRP procedures
• Complete dossier compilation for centralised application
• Cell therapy ATMP (gastroenterology)

IMPDs / IBs / CTAs

• Advanced therapies cell therapy for bone / cartilage regeneration
• Therapeutic vaccines
• Analgesia
• Oncology – several Europe-wide projects from Phase I – IV
• Dermatology
• Metabolism
• Urology
• Parenteral nutrition and fluid replacement

Submission Management

• Experience and confidence for all types of EU MA submission projects
• Reliable coordination of FDA and ROW submissions
• Dedicated project management to comply with critical timelines

Notable achievements:

• Experience in Centralised, DCP, MRP and National Procedures
• NDA for FDA (USA)
• ASMF / DMF and Pharmacopoeial Certification procedures
• Experience with broad range of dossier types:
• NCE (New Chemical Entities)
• Biotech products and Advanced Therapies
• Orphan Drugs
• Generics and Biosimilars
• OTC
• Herbal drugs
• Veterinary medicinal products
• Medical Devices
• Cosmetics
• Food supplements
• Management of dossier finalization and submission
• On-line build-up of submission dossier
• Project management for schedule optimisation
• Full integration of ASPHALION staff into the project team
• Translation to local languages and coordination of final translations
• Readability test
• Responses to objections raised by the Authorities
• Preparation and attendance to oral hearings and break-out sessions
• Pricing and reimbursement

e-Submission

• eCTD and NeeS preparation according to latest standards and best practise guides
• Ad-hoc assistance for eCTD compilation projects with your choice of technology
• Lifecycle support for guaranteed compliance
• Technology assessment for e-standards implementation projects

Notable achievements:

• eCTDs in EU procedures
• First Spanish Consultancy submitting eCTD file in MRP
• Over 500 sequences prepared for our clients
• Multiple CPs prepared and submitted to EMA
• Baseline eCTD consolidations for CP products
• eCTDs compilation for ATMPs
• eCTD life cycle support (response documents, variations)
• Preparation and submission of IMPD, IB, CTA, and INDs (FDA), and more…
• FDA (USA)
• Certified FDA eCTD provider validated by FDA eCTD pilot procedure
• Consulting partner for EXTEDO
• In direct contact with EU authorities on development and implementation of new standards and guidance in EU
• eCTDmanager First-Level-Support for 10+ companies
• Several projects of company-wide eCTD implementation
• Technology-assessment
• Compilation of user requirements and functional specifications
• Preparation of SOPs and WIs
• Training, workshops and implementation
• Regulatory Information Management with global databases
• Expertise on large number of RIM tools and processes
• XEVMPD experts
• XEVMPD submission for over 15 clients
• Experience in data handling and data processes
• Direct contact with EMA
• Direct collaboration with tool developer

Optimised Product Maintenance

• Maximum efficiency for Variations, Renewals and Notifications for all types of EU/ROW products
• Drug Safety services including preparation of PSURs and Clinical Expert statements
• Pharmacovigilance and local representative

Notable achievements:

• Many years of experience with variations, renewals and notifications
• Complete outsourcing of product maintenance for Big Pharma companies
• Advice on feasibility and strategy for new indications
• Waiver of bioequivalence in CMC variations
• Review of promotional materials
• Regulatory compliance on promotional activities
• Audited pharmacovigilance system
• Preparation of PSURs and Clinical Expert Statements
• Handling and translation of ICSRs and follow ups
• Bibliographic searches in local literature
• Electronic transmission to the Authorities
• Local pharmacovigilance contact in Spain

Training

• Regulatory Affairs seminars for experts or beginners
• Technology workshops for e-Regulatory Affairs
• In-house training

Notable achievements:

• ASPHALION staff frequently present at international conferences and symposiums
• ASPHALION collaborates with learning institutes andpharmaceutical associations
• Countless in-house workshops and trainings performed
• In-depth European RA
• Updates on European RA
• e-Submission: introduction, implementation, optimization and best practise
• Variation regulation and its use in eCTD
• xEVMPD: requirements and solutions
• FDA basics: getting started in the US
• Commercialization of medical devices
• Paediatric regulation: PIPs, waivers, and deferrals