PharmaAccess Regulatory Affairs

Regulatory Affairs

The pharmaceutical, biotechnology and medical device industries are among the most highly regulated industries in the world. Regulations are applied to all products from those that are new and innovative to those that are long established.
PharmaAccess collaborates with companies to bring products to the market in the most efficient and cost-effective manner, within an evolving and increasingly challenging regulatory environment.
PharmaAccess Regulatory Affairs team has a vast experience in delivering fast, high-quality product approval and efficient license maintenance..
Our complete and comprehensive expert understanding of the requirements in regional regulatory affairs, coupled with a strong commercial awareness, ensures we devise an optimal regulatory strategy for the registration of your new innovative drug, medical device, generic medicine, and line extension.

We bring our significant expertise to strategic and operational aspects of regulatory affairs in the pharmaceutical industry to guide you through the complex of regional and national requirements to get your product to market as quickly as possible with an optimal price.
For medicines, our experts will advise on all aspects of product lifecycle and our regulatory strategy services. It is vital to get organized and prepare target SPCs, PILs, Artworks, Brand Name, e-CTD, well in advance of marketing authorization applications. Our team is ready to prepare these for you with the application of their significant regulatory knowledge and experience, to guide you through the regulatory pathway.
As part of our regulatory affairs functions, we will devise strategies to extend the lifecycle of your product through strategic line extensions to ensure you gain the maximum commercial return from your products.

For medical devices & nutraceuticals

Our experts will use their deep regulatory knowledge to advise on the correct classification of your product. Their experience is used to help you comply with all the applicable regulations and standards, to prepare technical files and design and implement a fully compliant registration documents.

PharmaAccess Regulatory Affairs Team is highly experienced in

  • Advising on the options for the legal basis for your application;
  • Evaluating the procedure options for your product both in terms of the options available and the pros and cons of each option
  • National applications which are submitted in member states;
  • Centralized applications which are submitted to the GCC-DR office;
  • Understanding the implications for each option including life cycle maintenance and commercial factors

Get in touch with us today to find out more!

Get in touch with us today to find out more!

Product Life Cycle Management

Managing a product throughout its life cycle is as important as getting through the initial approval. Not only is it a regulatory requirement to keep your product up-to-date and to remain compliant but it may also help the commercial success of the product.

International business expansion; help with entering the GCC regional market place

Submission Dossier Preparation

Label Preparation & Review

e-CTD Publishing & submission

New product applications; Country regulatory feasibility surveys

Submission to regulatory agencies; National or Centralized procedures

Approvals/MA; project management, harmonization activities

Post approval Variations and Renewals

Regulatory Agency Interactions Support

Regulatory Strategy, Gap Analysis & Classifications

Expedited Approval Pathways

PharmaAccess – Helping Pharmaceutical Brands Succeed!

PharmaAccess – Helping Pharmaceutical Brands Succeed!