importance of regulatory consulting engagement

The Life sciences industry is undergoing a plethora of dynamic changes on a global scale as far as regulatory consulting engagement is concerned. With globalization opening immense potential for huge business gains across rapidly growing markets, the strategic move to manufacture, market, and operate in global economies is increasingly meeting the complex challenges of stringent regulatory adherence requirements. In such a scenario, companies are increasingly looking to engage with the right Consulting Partner who can help them successfully navigate the regulatory challenges. The aim is to achieve optimized Regulatory and Compliance procedures with minimal risks through an optimal cost effective option. The Regulatory Affairs consultation provides necessary assistance during the pharmaceutical development process, which in turn helps companies in the implementation of a Global Regulatory Strategy. The major concern is how well a consultant analyses the Regulatory Compliance obligations and values the company’s needs. Here are some of the common parameters of regulatory consulting services that, in principle, help a company measure the credibility and derive value out of its consultative engagement. Right Partner Vs. Right Value Identifying the right regulatory affairs consultant, possessing the expertise, knowhow, and experience, is the most critical aspect.  Solution partners with Industry expertise can leverage their consultative and solution implementing experience to ensure a company streamlines the regulatory processes to meet the objectives, within mandated timelines and also saves significantly on cost of compliance. They also impart knowledge regarding the current standards and latest rules of regulatory agencies, analyze the gaps and the needs to meet them and provide the action points to publish the submissions within the stipulated time. Look out for some of the few challenge areas mentioned below that a Consultant should address effectively:

  • Follow the mandatory processes like development, preparation, assembly and submission of technical documentation for the purpose of marketing authorization applications
  • Meet the requirements of regulated, semi regulated and non-regulated standards
  • Understand all the centralized, decentralized, national and mutual recognition procedures
  • Handle all the pre-submission activities, including the orphan drug designation
  • Compile all types of drug submissions like NDS, NDA, BLA and MAA
  • Convert the paper or non-eCTD electronic submissions (NeeS) documents into electronic form through upgraded eCTD software
  • Communicate with the Regulatory authorities and acknowledges the comment letters, assessment reports and quality control reports within the stipulated time
  • Organize scientific advice meetings with Regulatory agencies for a smooth drug development process
  • Follow the European Clinical Trial Authorization (CTA) and ethics committee applications submission protocols
  • Provide diligent data evaluations and risk management plan
  • Evaluate and effectively handle change controls for EU and other regions

There are other critical areas that will demand your attention during a compliance life cycle. And, if you find yourself asking all the questions but getting no definitive solution roadmap, it’s time to look for a partner who brings the experience, the expertise and, more importantly, who brings value to you! Regulatory Consulting Services have this to offer -

  • Recognition of suitable requisites w.r.t regulatory, market and customer drivers
  • Yielding implementation on assurance process
  • Offering direct access to on-call consulting support
  • Conceiving regulatory blueprint and submissions accordingly
  • Research on Q&A style support
  • Outlining hazard limits and residue tolerances
  • Monthly reports on health as well as environmental requirements
  • Real-time Information Change Notices (ICNs) on relevant modifications to health and environmental requisites
  • Validating disclaimer requests and feedbacks
  • Ensuring safety of the medicinal products and vigor evaluations
  • Conducting risk estimation w.r.t human health and environmental conditions
  • Programmed evaluations of unique chemical hazards
  • 3rd party technical interface

Regulatory consultancy involves instruction on au courant approved applications and hand-out list of submissions. The regulatory intelligence services usually work on the following verticals -

  1. Orphan drug (Orphan drug is a medicinal agent that is prescribed for treating a rare medical condition known as orphan disease)
  2. Biotech products and advanced therapies
  3. Biologicals
  4. Generics
  5. Biosimilars
  6. NCE’s

As Regulatory consultant and global solutions partner to several Top 10 Fortune companies, handling end-to-end multi-geo Regulatory Affairs responsibilities across their Top 20 global brands, Freyr is best positioned to provide proven expertise and tailored services that put you in total control of your entire global Regulatory compliance obligations. With strong skills in designing clinical trial applications, Freyr offers the seasoned resources for import licenses and Qualified Person (QP) for GMP certification, hands-on submissions and insurance certificates to name a few.