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Regulatory Affairs

Compliance expertise is guaranteed with our RA experts located around the world. PharmaLex is uniquely positioned to ensure that your products meet all regulations and laws no matter where you are. Our teams have successfully managed multiple large-scale projects through to the post-market phase. We can position you for success from the initial development of new medicines all the way through to market readiness. We are your strategic partner, playing a key role in your success by outlining a tactical, target-oriented plan, flexible based on the ever-changing regulatory field.

Not sure what you need? Let us design a work flow that fits your expectations in regards to results, deadline and budget. Whether you need us for one day or five days per week; part-time or full-time; on-site or remote, our team will evaluate what will be most beneficial to you and your project. Partnering with PharmaLex, gives you access to world-wide expertise. Contact us for a review of your needs to provide you with the most appropriate service model for your project.

apple-touch-icon-16x16 Customer On-Site Support
Flexible staffing options are a key service we offer to our clients. Whether you need large-scale on-site support, or require assistance due to an unexpected vacancy in your team, we provide comprehensive RA services adhering to all guidelines and legislations and – beyond compliance – provide you with effective and efficient solutions.

apple-touch-icon-16x16 Application Services
PharmaLex provides a full-range of application services for human and veterinary medical products and medical devices. With experts worldwide, we manage regulatory activities and processes, from chemicals and biologicals to biosimilars and herbals. Coordinating a product through the lifecycle or just through the authorization phase, we are able to provide a thorough application plan.

We guide you through the initial marketing authorization application, helping you to achieve approval to bring a newly developed drug to market. With professionals in all aspects of Regulatory Affairs, we provide customer-specific strategies to maintain efficiently your optimized products in a competitive environment.

apple-touch-icon-16x16 Chemistry, Manufacturing and Controls (CMC)
We are regulatory experts in all aspects of CMC and pharmaceutical quality. PharmaLex is fully equipped to author, review and revise CMC documentation in collaboration with your specialists from production, quality control and pharmaceutical development, submission and LCM Management. We can do so from anywhere and for any health agency in the world.

We can seamlessly coordinate with your specialists and assume complete responsibility for safeguarding regulatory compliance throughout the respective product life cycle. Whether it is a case of first-time submission, change control or maintenance throughout the life-cycle, our multi-disciplinary teams take care of GxP, technical writing, regulatory strategy, change control and submissions on a global basis.

Our experts are continuously updating their skills and knowledge to provide the best understanding, interpretation and utilization of regulatory guidance and regulations. We are up-to-date on industry and government agency best practices and trends.

We provide extensive due diligence anticipating what an assessor will need or require. Our team provides the complete quality dossiers that contain all necessary documents including CTD Module 3 and 2.3, IMPD, IND, ASMF/DMF, CEP.

apple-touch-icon-16x16 Strategic Outsourcing
The regulatory environment for the pharmaceutical industry is constantly changing with increasing demand for pre- and post-approval activities. The maintenance of approved products might often not be the key strategic focus of companies, however is essential and critically important for product compliance.

As a result, regulatory outsourcing of maintenance activities has become a new trend in the pharmaceutical industry, enabling companies to focus their resources on core strategic competencies, while reducing complexity and moving to more scalable and flexible resource models. Outsourcing models range from tactical outsourcing of single tasks or functional activities to preferred provider models and ultimately strategic partnership. The latter normally comprises large volume, long-term outsourcing programs, managing full global regulatory responsibility for parts of the product portfolio (typically > 40 product brands). All regulatory activities are handled by PharmaLex on a global level for countries worldwide, with interfaces to different customer functions such as local affiliates, manufacturing sites and PV.

Depending on your needs, we provide dedicated program governance structure with clear roles and responsibilities with a common decision board including upper management of PharmaLex and customers to help integrate our teams to achieve agreed results. A clear process plan is at the base of our partnership detailing how our team will interact with your staff and implementation of action plans including Key Performance Indicators, key milestones and budget. Currently, PharmaLex is successfully managing several major outsourcing programs with different clients globally.

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Combining our global reach and years of experience, strategic outsourcing is a viable solution to maintain your products throughout the life cycle while ensuring the highest quality and compliance.

apple-touch-icon-16x16 eSubmission Services

PharmaLex offers full electronic submission services with regard to eCTD preparation, publishing and submission activities in Europe, US, Switzerland and international eCTD adopters like the countries of GCC (Gulf Cooperation Council). Our dedicated team ensures the technical quality of the source documentation, the technical validity of the final submission package according to applicable global and regional eCTD specifications and requirements as well as the timely submission to the authorities via submission gateways and portals. eCTD publishing for submissions across various regions worldwide has been part of our service portfolio for over 10 years.

Furthermore, eSubmission services include consulting services in all areas of Regulatory Operations, e.g. transition to electronic submission, compliance with EU eSubmission Roadmap, submission process optimization, implementation of efficient Regulatory Information Management (RIM), compliance with XEVMPD and IDMP requirements as well as other innovative topics in the framework of Regulatory Operations.

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Our experts are members of various eCTD and related working groups across the industry, acting as well-known speakers and session-chairs on international eCTD- and Regulatory Operations-related conferences and seminars.

Want to know more? Here are just a few eSubmission services we provide:

  • Country-specific eCTD compilation, publishing and validation for submissions in Europe, the USA, Switzerland, GCC, Canada and more.
  • Fully electronic submissions via CESP, EMA gateway and FDA ESG
  • Regionally adapted PDF publishing for RoW submissions and non-eCTD based submissions
  • Supporting you on the switch to eCTD
  • XEVMPD and IDMP implementation
  • Consultancy services for submission process optimization, Regulatory Operational Excellence and effective Regulatory Information Management