Regulatory affairs services are protecting public health and it is also controlling the safety and efficacy of products. These areas are including pharmaceuticals, veterinary medicines, medical devices, pesticides, agrochemicals, cosmetics, and complementary medicines. Regulatory affairs services are helping companies to plan and manage these pharmaceutical and medical product development programs. These qualified experts are provided consulting advice from the early pre-IND/pre-CTA/pre-IDE stage of pharmaceutical development.
The role of the regulatory professional
Regulatory professionals are responsible for:
They are keeping track of the ever-changing legislation in all the regions in which a company wishes to distribute its products.
Advising on legal and scientific restraints and requirements.
Collecting, collating and evaluating scientific data.
They are presenting registration documents to regulatory agencies and carrying out any subsequent negotiations necessary to obtain or maintain marketing authorization for the products concerned.
It is giving strategic and technical advice at the highest level in their companies, making an important contribution both commercially and scientifically to the success of a development program and the company as a whole.
Helping the company avoid problems caused by badly kept records, inappropriate scientific thinking or poor presentation of data.
The regulatory affairs department will be taking part in the development of product marketing concepts that are commonly required to approve packaging and advertising before it is used commercially.
There are some services of regulatory affairs services the following:
Drug Substance Services: DMF, IND, Manufacturing, Import & Exports
Drug Product Services: NDA, ANDA
Pre-IND and Pre-NDA meeting with FDA
Writing and compilation of INDs, NDAs, ANDAs, 505(b) (2) and supplements
Providing the clearances
Orphan Drug Submissions
Regulatory support for clinical trials, Facility Inspections
CMC (Chemistry, Manufacturing, Control) and Pre-Clinical toxicology
Regulatory agency interaction
Case Report Forms (CRFs)
Product information (SPC, PILs)
RLD Sample Procurement
Pricing and Market Authorisation Approval
Product Life Cycle Management
Regulatory compliance is an organization’s cause for laws, regulations, guidelines, and specifications relevant to its business processes. Violations of regulatory compliance regulations are resulting in legal punishment including federal fines.
Why regulatory compliance is a big deal?
These rules have increased since the turn of the century, regulatory compliance management has become more prominent in a variety of organizations. A primary job function of these roles is to hire employees whose sole focus is to make sure the organization conforms to stringent, complex legal mandates and applicable laws.
Regulatory compliance processes
• Regulatory compliance processes and strategies are helping guidance for organizations as they strive to attain their business goals. Audit reports proving compliance help companies to market themselves to customers, for example, SOC 1, SOC 2, and SOC 3. These reports are allowing vendors to prove compliance with regulations such as the Sarbanes-Oxley Act.
• These compliance processes are helping clients build trust in the processes of the business, as well as potentially improve the profitability of the company in the process.
• Some regulatory compliance rules are designed specifically to secure data protection. Poor data breach compliance processes are hurting customer retention and negatively impact the company’s bottom line.
• The frequency of data breaches is continuing to increase consumers that are placing more trust in companies. These are following regulatory compliance mandates designed to protect personal data.
Challenges with compliance
Compliance rules are costly from an infrastructure and personnel standpoint. As companies are required to spend capital in order to comply with compliance laws and regulations, they must be trying to appease stakeholders and maintain business processes by turning a profit. These financial challenges surrounding compliance are sharping in highly regulated industries such as finance and healthcare. There are following the ho to maintain regulatory compliance:
• Determining how emerging regulations will influence the business direction and the existing business model
• Incorporating and developing a compliance culture are promoting this culture throughout the organization
• Hiring compliance roles and accountabilities compliance functions are required by the legal, compliance, audit and business departments
• Anticipating compliance is trending and integrating regulatory processes that are increased efficiency