regulatory affairs

Regulatory

A bespoke service giving you comprehensive solutions in a proactive framework.

Here at PDS we offer a comprehensive range of regulatory services to complement our pharmacovigilance business. We offer a bespoke regulatory service that will work alongside client companies becoming integral to your team.

Our team together with a network of highly experience regulatory consultants can help you deliver results at all stages of the regulatory process. We can act as your ‘add-on’ regulatory department, to manage the entire process from the definition of initial regulatory strategy through to dossier submission and authority approval.

Alternatively, we can provide ‘ad-hoc’ support to add specific expertise and specialist knowledge at any stage of the regulatory process, or to provide additional professional resource as you need it.

Our team and network of expert consultants are experienced in regulatory project management, leading and providing regulatory input to cross-functional project teams, and meeting project deadlines.

Regulatory Strategy

Strategic advice for expanding registrations throughout the EU and other markets;

  • Guidance on the choice of regulatory procedures, Generics, Combination Products, Herbals, Cosmetics and Borderline Products, Devices
  • Design of clinical trials
  • Advice on ICH and EU Guidelines and Regulations (existing and pending)
  • Recommendations for updating and conversion of existing or historical dossiers (NTA to eCTD conversions)

Due diligence

  • Dossier review and gap analysis
  • Requirements for any essential pre-submission data generation
  • Feasibility, risks and costs of proposed applications

Scientific Advice

  • Guidance on requirements or full management of this process

New Licence Applications

  • EU Applications; Centralised, Mutual Recognition, Decentralised, National
  • Clinical Trial Applications (CTA)
  • Full Marketing Authorisation Applications (MAA)
  • Abridged Marketing Authorisation Applications (MAA)
  • Dossier preparation: Common Technical Document (CTD)
  • Dossier publication: eCTD, NeeS
  • Advice and support for authority requested responses Communication with regulatory authorities; obtaining informal advice, managing regulatory applications from submission to approval, clarification and negotiation of data requests.

Post-authorisation Support for Existing Product Portfolios

Chemistry, Manufacturing and Control (CMC) compliance:

Gap analysis and recommendations due to changes in legislation

  • Authority requested updates
  • Manufacturing and supply changes
  • Drug Master Files
  • Site Transfers

Product Development:

  • Reclassifications (POM to P, P to GSL)
  • New Indications

Medical Information:

  • Core Company Data Sheets (CCDS)
  • Summary of Product Characteristics (SmPC)
  • Patient Information Leaflet (PIL) and product labelling
  • Website support (eMC, product information)
  • Claims and Advertising Review
  • Harmonisation of EU and National requirements
  • Harmonisation of product ranges

Compilation and submission of;

  • Variations; Type IA, IB, II, CCC scheme
  • Labelling changes
  • Renewals
  • Change of Ownership
  • Periodic Summary Assessment Reports (PSUR)

Have a question? Just call +44 (0) 1476 512395 or email info@puredrugsafety.com

Glossary of Terms

SOP : Standard Operating Procedure

QRD : Quality Resignation Document

PIL : Patient Information Leaflet

SmPC : Summary of product Characteristics

MRP : Mutual Recognition procedure

DCP : Decentralised procedure

CTD : Common Technical Document

CMS : Concerned Member State

RMS : Reference Member State

MA : Marketing Authorisation

CEP : Certificates of Suitability

DMF : Drug Master File

API : Active Pharmaceutical Ingredient

ATC : Anatomical Therapeutic Chemical classification system

ANDA : Abbreviated New Drug Application

NDA : New Drug Application

EPO : European Patent Organisation

RMP : Risk Management Plan

MHRA : Medicines and Healthcare Products Regulatory Agency

PARS : Public Assessment Reports