Regulatory Affairs

Full Regulatory Support for API Developers and Manufacturers.

Leverage Regulatory Strategy

To successfully comply with regulatory requirements and avoid penalties, rejection and delays, Life Science businesses need to be aware of the challenges posed by different laws operating in different market regions.

Don’t risk losing quality and trust: choose the right training, guidance and support.

Manage product’s approval and registration
Speed up product’s launch
Reach different countries and assure global coverage
Consistently keep products on the market
Coach R&D to collect the right data from the first stages

Pharma support

Regulatory and Strategic Development

Regulatory Strategic Master Plan and Feasibility Studies
Bioequivalence Study Designs review
Full Development Plan
IND/IMPD compiling
Scientific Advice, Protocol Assistance & Parallel Advice requests
M&A Due Diligence SupportDrug Development Trainings

Regulatory Services for Market Authorization

Full support for medicinal product registration
Drug life-cycle management: Variation/Change Application Dossier, EU renewals, EU line extension
Promotional activities: Regulatory review and support for Approval of Advertising, Educational Material to HCP/HCO, Scientific Service Quality System
Dossier reformatting & Electronic submission
Regulatory Department Compliance Assessment

Regulatory Intelligence

We can provide regular updates, to make you aware of regulatory requirements applicable to your portfolio, and insights on the expectations of the regulatory authorities.

All in your first language.

Medical Device support

MD Regulatory Services

US Agent
510K
Device Listing
Establishment registration
Regulatory intelligence
Regulatory strategic plan
Technical File preparation

MDR & IVDR Support

Compliance Support Consultancy
Clinical Preparation
Performance Evaluation Plan
Post Market Follow Up
Post Market Surveillance
Manufacturers and Device Registration
Recording and Reporting Incidents
Implementation of Unique Device Identification (UDI)
Device Classification
Assessment

Get in touch.

To easily navigate the increasingly complex regulatory market and sell your products in EU, US and Canada, LATAM, MENA, CIS, Africa and APAC.