Optimization and accomplishment of all Regulatory Affairs related issues

Human Medicines
At this stage our services provide:
  • Suitable regulatory advice
  • Information about the patent status of the new product
  • Regulatory intelligence on what is already on the EU market
  • Development on regulatory strategy, including type of procedure

Analysis of the current stage of the product development before proceeding with the clinical program. Learn how to show an in vivo/in vitro correlation for your product.

Our consultancy services include:
  • Follow-up/advice from Health Authorities
  • CEP/ DMF analysis
  • Preparation of Module 3 and Quality Overall Summary

While developing a pharmaceutical form different from the originator’s one some non-clinical local tolerance studies may be required. For such cases, outsourcing may be the best solution.

Our services include:
  • Analysis and advice on your non-clinical program
  • Preparation of Quality Overall Summary of Module 4
  • Preparation of Quality Overall Summary of Module 2

While preparing clinical studies to demonstrate bioequivalence to the originator product, you may need advice on how to optimize your study protocol.

Our services include:
  • Preparation of Module 2
  • Preparation of Module 5

Learn what the best regulatory submission track(s) is for your product.
Plan early submission by preparing CTD hand in hand with your development program, thus reducing time to market in months.
If your company does not have an EU presence we can take the responsibilities of the MA Holder until you find a marketing partner.

Our services include:
  • Preparation of Product Information ( SPC, Patient Leaflet and Labeling )
  • Preparation of a Pharmacovigilance System
  • Readability tests of the Patient Leaflets
  • MRP (Mutual Recognition Procedure) and DCP (Decentralized Procedure) management
  • National Procedure management
  • e-CTD/NeeS submission

Extending the period of data exclusivity, e.g. Marketing Authorization for Pediatric Use
Preparation of the therapeutic indication extension
Learning how to protect from parallel imports
Increasing the number of markets with a Certificate of Pharmaceutical Product (CPP)
Increasing market
Management of your MA portfolio until a number of products is reached, requiring you to have your own in-house regulatory staff.

Our services include:
  • Compliance (variations)
  • Renewals
  • MA Transfers
  • Pricing and reimbursement

Pharmacovigilance provides an assessment of the risks and benefits of the medicinal products, ensuring a permanent and continuous monitoring and ensuring the safety of those medicinal products. This is an assigned responsibility of marketing authorization holders.

Our services include:
  • Preparation of PhV procedures
  • Periodic research of scientific literature
  • Assessment and electronic reporting of adverse reactions
  • Preparation and submission of Periodic Safety Update Reports (PSUR)
  • Preparation, submission and implementation of Type II safety variations
  • Information/communication with the Competent Authority
Veterinary Medicines
  • Development of the products
  • Quality phase
  • Safety phase
  • Efficacy phase
  • Technical Advice
  • Technical Responsibility
  • Registration, launching the products on the market
  • Cosmetovigilance
Medical Devices
  • Technical Advice
  • Registration, launching the products on the market
  • Vigilance
Food Supplements
  • Technical Advice
  • Registration, launching the products on the market (e.g. pharmacies etc.)

Main Clients