A trend of outsourcing regulatory affairs services has increased considerably. A lack of talented regulatory affairs professionals and stringent FDA regulations has contributed to the rising need for experienced FDA regulatory consultants. Pharmaceutical and device developers are focusing their energy in research and development operations while partnering with FDA regulatory consultants to provide regulatory affairs services. Many pharmaceutical and device companies have found that utilizing regulatory consulting firms has helped to reduce costs associated with product development. Third-party FDA regulatory consultants can help their clients in a variety of areas including cost efficiency, decreasing regulatory submission time, and strategic planning in the development process. These are a few factors that are contributing to the rise in demand for regulatory affairs services. Some of the world’s largest pharmaceutical companies have contracted with FDA regulatory consultants due to internal issues such as department delays and lack of expertise. Pharmaceutical and device companies utilize regulatory affairs services to avoid additional work load and the costly expense of hiring extra personnel. Regulatory affairs services include items related to 510k, IND, ANDA, scientific writing, drug master files, adverse reaction reporting, CMC, SOPs, and quality assurance. Selecting the right FDA regulatory consultants is important since they can play a critical role in expediting an FDA approval for a drug or device. Communicating at an early stage with FDA regulatory consultants is recommended since strategic development planning should start well in advance of any project. A pharmaceutical or device company should investigate the relevant experience of any potential regulatory consulting firm and ensure that the organization has excellent writing and communication skills. Some good questions to ask when looking to outsource regulatory affairs services are listed below:
- Does the firm have an excellent history in obtaining FDA approvals, if so what is the percentage?
- What percentage of their clients return for future projects?
- Who will lead the project and what experience do they have? How many years has the project leader been employed with the regulatory consulting firm?
- What is the firm’s staff turnover rate?
- Has the regulatory consulting firm ever missed a submission deadline?
Product development takes a considerable amount of time and resources to navigate through the drug development and commercialization process. These simple questions will give greater insight to the regulatory consulting firm’s expertise and reliability. A consistent team that will be a part of your project from the beginning to the end is vital to the success of your FDA approval. Preventable delays in the product development process are costly to developers and to the community of patients whose health may be dependent on these new therapies or devices. Outsourcing regulatory affairs services including FDA engagement to commercialization strategies, will allow drug and device developers to concentrate on their innovative expertise. The FDA regulatory consultants are experts in containing costs while bringing their client’s product to market faster.
Christina Sanchez Miller, MPH has over 20 years of management, biologics, quality assurance and research experience in the medical field. She is a published author in scientific books, papers and has presented at several international conferences. Christina has developed medical applications in the biologics field. Her experience includes operations and consulting in FDA Adverse Event Reporting, FDA Product Deviation Reporting, FDA 483’s, cGTP’s, infection control, certified ISO Class 5, 7, 8 development and maintenance, QIC and auditing.
Pharmaceutical Development Group (PDG) is a global scientific & regulatory consulting firm with extensive experience in the strategic development of drug products, biologics, medical devices, combination products and FDA regulatory affairs. PDG is a regulatory consulting group focusing on NDA regulatory services, FDA ANDA submissions, and IND consulting services. PDG is a subsidiary of Biotech Research Group Corporation.
The opinions and statements in this blog are those of the authors and do not necessarily reflect those of PDG. This blog is based on personal experience and reviews of information publicly available or identified in other database searches.