Building the Global Regulatory Affairs Strategy

Regulatory Affairs

Every drug is different.  Every therapeutic area is different. Finding experts who understand the different diseases, and the different types of drugs sufficiently to competently build and execute the strategy is not an easy task.  Building the Global Regulatory Affairs Consulting strategy involves telling the story of the drug from research all the way to approval.  The expert working on the regulatory strategy must be able to discern the strengths and weaknesses of the drug, and how they will be addressed in the development program.  In writing the strategy, the expert must be able to explain the way forward.  After the strategy is developed and committed to writing, leadership skills are required to enable the team to implement the strategy. Global Regulatory Affairs Expert play a vital role in developing the global strategy, to ensure approval can be achieved in as many countries as possible. Speid & Associates are able to provide support in the following ways:

  • Research and drug discovery strategy development
  • Leadership of the project team
  • Development of the project team’s understanding of the drug development process
  • Target Product Profile development
  • Regulatory Strategy development
  • Drug Supply strategy development

Regulatory Affairs Operations

Regulatory Affairs Operations differs from Regulatory Affairs Strategy.  Operational Regulatory Affairs Consulting involves the operational aspects of regulatory affairs. It is task based, rather than strategic. Professionals working in regulatory affairs, must be able to compile the applications that are filed for clearance to start clinical trials, and to secure approval to begin to market the drugs.  Speid & Associates provide operational regulatory affairs consulting to the expert level. Areas of operational support provided by Speid & Associates are as follows:

  • eCommon Technical Dossier Strategy development
  • Document strategy for inlicensed molecules
  • Organization for the writing task Selection of experts
  • Organization of external and internal experts to develop the MAA, NDA and BLA documents
  • Organization for the Quality Control of the near final application

Regulatory Affairs Experts

Regulatory Affairs Experts are the people who have reached the top of the Regulatory Affairs profession. They have a minimum of 20 years of experience. They have secured approvals from many regulatory authorities, and may even have experience in securing approvals under conditions of appeal.  Regulatory Affairs Experts have advanced degrees such as Ph.D.s., and are often scientists that have deep knowledge of the area that they specialized in during their doctoral studies. These doctoral studies enable them to competently analyze, and present data. Scientists are able to collaborate with experts in a deeper way than with regulatory specialists who do not have the skills to analyze and competently present data, including on scientific subjects that they are not specialized in. Speid & Associates are  recognized regulatory affairs experts.

Our Regulatory Affairs Experts will help with the following challenges:

  • Analysis of scientific data
  • Conduct of appeals after rejection of the application by major regulatory authority(-ies)
  • Development of the Regulatory Strategy
  • Development of the strategy for meetings with major health authorities
  • Creation of the product labeling

Regulatory Affairs Speciality

The pharmaceutical industry is an important industry because it seeks to develop new treatments to treat the myriad of diseases that exist.  Every aspect of the research and development of new medicines is regulated.  What does this mean in practice? This means that specialized knowledge and understanding is needed in order to navigate the regulations, which can take the form of rules, guidelines, laws, and regulations.

The speciality that provides the support to scientists, and others involved in developing new treatments, is called Regulatory Affairs.  Regulatory Affairs professionals, are not only experts in the scientific subjects involved in the research and development of new treatments, but they must also have excellent communication skills. They must be able to communicate extremely well in writing as well as orally.  Speid & Associates are recognized experts in new medicine development.

Our Regulatory Affairs Experts will help with the following challenges:

  • Working out how a drug should be developed
  • Determining the regulatory road blocks that could prevent the drug from being approved
  • Finding the most appropriate patient group for the new drug
  • Many other areas of expertise, as needed

Regulatory Affairs Services

Because the regulatory landscape can vary from one country and one region to another, regulatory affairs experts must be able to understand the differences and similarities between the regions and territories, and how to create a uniform regulatory strategy for a development program.  Speid & Associates, a top-notch regulatory affairs consulting firm, is able to provide the following Strategic Regulatory Affairs Consulting Services:
  • Target Product Profile definition
  • Regulatory Strategy creation
  • Global Regulatory Strategy creation
  • International Regulatory Strategy creation
  • 505 (b) (2) strategy development

The Regulatory Strategy

The regulatory professional builds the regulatory strategy.  The regulatory affairs consulting process involves creating the road map for the molecule to go from point A all the way to Z, i.e. from research to approval and commercialization.  Companies that do not build the regulatory strategy for their molecules, or programs are increasing the chances of failure for their programs.  Speid & Associates provides support in the following areas to create the Regulatory Strategy:
  • Target Product Profile definition
  • Product label definition
  • Regulatory Strategy development
  • Patient need definition
  • Chemistry Manufacturing Controls strategy
  • Clinical Research strategy
  • Manufacturing strategy support – “Speid & Associates One Stop Shop Process”