Regulatory strategy advisory

Over the years, we have gained extensive experience with local agency regulations in EU member states and Russian & CIS regions. Pharmaceutical companies are constantly developing new product pipelines and subsequently maintaining existing products by releasing different dosage strengths and forms. Our role here is to conduct professional feasibility study and provide comprehensive report as basis for our partners to steer their regulatory strategy.

Our report includes:

  • Determination of legal bases for submission
  • Advisory of best suited submission procedure 
  • Recommendation and nomination of countries for DCP or MRP submission based on market viability and client’s strategic target market.

Readability testing for PILs

One of the necessary requirements for drug registration is that drug products information leaflet must be readable by intended patients. Ineligible patient’s information leaflet PIL could jeopardise all the hard work that was put in before submission.

We have qualified testers to perform readability testing of your product patient’s information leaflet PIL.  We can also provide final mock up if requested.

eCTD data dossier conversion

 

As soon as you have made a decision to go further with your product registration, such dossier must be in eCTD format according to EU medicines agency guidelines.

We translate and convert your dossier from any format to the required format in accordance with local regulatory directives.

As soon as you have made a decision to go further with your product registration, such dossier must be in eCTD format according to EU medicines agency guidelines.

We translate and convert your dossier from any format to the required format in accordance with local regulatory directives.

Medical device services

We can manage complete registration and notification of medical devices in EU. Our partner contract research organization is ready to conduct trials and other studies.

  • Complete registration management to CE mark
  • Eudravigilance services
  • Clinical trials
  • Distribution and supply
  • New market evaluation and feasibility study
  • Marketing and sales of medical devices

Dossier GAP analysis 

The importance of ensuring gap free dossier could not be over emphasized wetter you are submitting for market authorization, purchasing or selling dossier for technology transfer or formulation development an expert analysis is inevitable.

Our experts have years of experience working with regulatory authorities in EU, Russia and CIS regions which translates to faster registration and submission.

Submission management

For a successful submission we design a roadmap in collaboration with product owners. This service includes determination of international and local regulatory requirements and develop robust plan to comply with national laws in each country of submission.

We secure favourable submission time slots where possible and maintain constant communication with local regulatory authorities in order to speed up approval processes.

Our security and data management process is aimed at providing unequal level of confidentiality and data integrity.

Regulatory affairs project outsourcing

Our clients rely on our highly experienced and qualified regulatory experts to support their regulatory project as a managed service. This is different from typical outsourcing because we simply multiply your intellectual capacity without increasing your overhead cost.

  • Don’t have enough manpower to handle your regulatory projects or running behind project delivery schedule?
  • Are your experts overloaded?

PCS EU Group can step in and complete the project from current state to end. Some projects are just one time or an occasional task that requires expert handling, no need to hire and fire a staff due to redundancy and overhead cost, we can perform such tasks at a moment’s notice. You can rely on our highly qualified experts with over 15 years’ experience in regulatory affairs.

Pharmacovigilance

During commercialization of medicinal product after obtaining market authorization from European medicines agency. EU law mandates that EMA enforces monitoring of products in the market in order to observe, investigate or and report adverse effects and adverse events in local member states. In some Member States, regional centres are in place under the coordination of the national competent authority please see our PV coverage areas below:

  • Writing and Review of Pharmacovigilance SOPs
  • EU & Local QPPV  Services
  • Writing Risk Management Plan (RMP)
  • Compilation and update of the DSUR
  • Compilation and maintenance of the PSMF
  • Local literature searching
  • Interaction with Eudravigilance database