- Pharma Regulatory Affairs Services
Pharma Regulatory Affairs Services
Explore our wide solutions portfolio
Services by Department
Medical and Scientific Writing
Our Medical and Scientific Writing team provides you with support to build the foundations of strong non-clinical and clinical developments.
Drug Development Consulting
Our Regulatory and Strategic Consulting team offers comprehensive support throughout the drug development process, from initial stages to market launch.
Chemistry, Manufacturing and Controls (CMC)
Complete CMC (Chemistry, Manufacturing and Controls) services offering broad expertise for strengthening compliance and shortening deadlines
Regulatory procedures
Systematic management of regulatory procedures for optimized time to market
Pharmacovigilance and Medical Devices Vigilance
Leave your Pharmacovigilance and Medical Devices Vigilance activities in safe hands with Asphalion
Regulatory Operations: eCTD Publishing and eSubmissions
Our team consists of Industry and Health Agencies’ experts with vast experience in electronic regulatory activities worlwide.
The team provides, among other services, publishing, submissions, software implementation and formatting activities by using the latest updated tools.
Regulatory Operations: Data Management
Offers a full range of services to provide a comprehensive support for data compliance for: Human medicines, Veterinary medicines and Medical devices.
Being a reference point for xEVMPD services, we are fully ready to support companies with: ISO IDMP, RIMS and DMS implementation.
MedTech
Our team of MedTech consultants, integrated together with our pharmaceutical and scientific consultancy services, will keep you ahead of market challenges and will help you meet all regulatory and quality requirements.
Horizon Europe EU-funded Programmes
Expert regulatory partner to ensure compliance with regulatory requirements of Horizon Europe EU-funded Programmes and with consortium objectives, maximizing requested benefit and impact.
Services by Stage of development
Preclinical development stage
Early assessment of your product to ensure smarter and faster development plan and proper regulatory pathway in the pre-clinical development stage.
Clinical development stage
Product-specific regulatory support for optimal transfer from pre-clinical data to a clinical development stage to meet with regulatory requirements
Registration
The correct Marketing Authorization application for a medicinal product, together with product particularities and complex regulatory requirements are key steps to be considered to ensure timely product commercialization in strategically defined markets.
Life-Cycle Management
Regulatory strategy and assistance through product life-cycle post-approval to ensure compliance, safety and optimal product maintenance.
Services by Product
MedTech
Our team of MedTech consultants, integrated together with our pharmaceutical and scientific consultancy services, will keep you ahead of market challenges and will help you meet all regulatory and quality requirements.
Biologicals
Our expertise with Biologicals helps you succeed in the complex development and registration of this type of product
ATMPs
Offering end-to-end solutions for Advanced Therapy Medicinal Products (ATMPs).
Drugs
Expertise and full range of services for small molecules.
Services by Region
Europe
Providing Vision and Experience to manage regulatory Submissions in Europe.
EU Local
Forget about the burdens: A robust management system of a strong network of partners to comply with local European regulations.
Spain
Our top leading history and experience in the Spanish market positions Asphalion as the best partner to ensure rapid commercial success.
UK Regulatory Affairs Services
Maintain your business effective and compliant in the post-Brexit UK market.
USA
Our expertise in expanding your market backed by our experience in the US.
Other countries
Assessing the regulatory context of ROW countries together with local partners to ensure the smoothest marketing.
