Regulatory agencies involve in every stage of drugs and acts as the interface (or bridge) between the pharmaceutical industry and drug regulatory authorities across the world. They play a vital role to meet the requirements of legal procedures related to the drug development process in a country. The regulatory body ensures compliances in various legal and regulatory aspects of a drug and ensures the safety, quality, and efficacy of medicines and medical devices. The various departments of regulatory affairs are as follows;
- Regulatory affairs (RA) in product management
- RA in clinical trials
- RA in R & D
- RA in QA & QC
- RA in the packaging department
- RA in licensing, distribution, and price control
1. Regulatory affairs (RA) in product management:
The key role of RA professionals is broader than registration of products, they advise companies both strategically and technically at the highest level. Their role begins right from the development of a product to make, marketing, and post-marketing strategies. Their advice at all stages both in terms of legal and technical requirements helps companies save a lot of time and money in developing the product and marketing the same.
2. RA in clinical trials:
RA personnel develops approaches to overcome delays and presents the finding of clinical trials to the regulatory bodies to get quick clearance thus reducing the time for approval of new molecules. At its core, the RA professional facilitates the collection. analysis and communication about the risks and benefits of health products to the regulatory agencies, medical and health systems, and the public. Operationally RA is responsible for assuring that government obligation, market-driven demands, and evolving scientific conventions are understood and addressed by various stakeholders
3. RA in R & D:
The regulatory affairs personnel work hand in hand with marketing and R&D to develop, innovative products that take advantage of new technological and regulatory developments to accelerate time to market. Employing adaptive clinical trial strategies, obtaining quick approval from regulatory authorities, and avoiding pitfalls in processes can accelerate the development of new products and help to reduce costly errors and time lags
4. RA in QA & QC:
RA officer will collect Master Formula Record, Process validation Protocol, Process validation report from the QA department. They review these documents for submitting the dossier to regulatory authorities to get marketing approval or register the product. The RA officer must check that the QA department complies with regulatory guidelines or not RA officer in the QC department collect the certificate of analysis (COA), stability studies, analytical method validation reports (AMV), and AMV protocol for submitting the dossier for registration of the product.
5. RA in the packaging department:
RA officer will require packing material samples and strips, blisters for documentation as proof for submitting to the regulatory authorities for getting the drug registration approval.
6. RA in licensing, distribution, and price control:
The regulatory authorities regulate the manufacture, sale, and distribution of drugs, licensing drug testing laboratories, carrying out pre and post-licensing inspections for the drugs manufactured and marketed in the respective states. They also regulate drug pricing, prescribing, and also special control if any such as narcotics
Role and Responsibilities of Regulatory Affairs Professionals
The various roles of professionals within regulatory affairs are as follows,
- Project management
- Submission management
- Maintenance management
- CMC specialist
- Pre-clinical/Clinical specialist
- Labeling expert
- Regulatory intelligence
- Global versus local regulatory affairs
Responsibilities of RA professionals
Some of the responsibilities of RA professionals are as follows;
1.They help pharmaceutical companies to comply with all of the system policies and lawspertaining to their business.
2. They advise on the legal and scientific requirements and collect, collate, and evaluate the scientific data that their R & D colleagues are generating.
3. They work with local, state, and federal or global regulatory agencies and staff on specific issues worrying their commerce. Le, working with agencies like the FDA or European Medicines Agency.
4 They give strategic and technical advice at the highest level in their companies on the regulatory aspects. This makes an important contribution both commercially and scientifically to the success of a development program and the company as a whole.
5. They coordinate, prepare, collect, collate, compile and review scientific data and all appropriate documents for example dossier (CTD) and submit them to regulatory authorities within a specified time frame in conjugation with the organization.
6. They prepare and review SOPs related to regulatory affairs. Review of BMR (batch manufacturing record), MFR (master formula record), change control, and other relevant documents.
7. They respond to queries as they arise, and ensure that registration or approval is granted without delay.
8. They provide training to R & D and pilot plant professionals.
9. They provide accurate and complete information about the quality, safety, and effectiveness of the product to physicians and other healthcare professionals.
10. They keep track of ever-changing legislation in all regions in which a company wishes to distribute its products.
11.They help the company to avoid problems caused by badly kept records, inappropriate scientific thinking, or poor presentation of data.
12. They present registration documents to regulatory agencies and carrying out any subsequent negotiations necessary to obtain or maintain marketing authorization for the products concerned.
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