Regulatory Affairs is a unique mixture of science and management to achieve a commercially important goal within a drug-development organization.
It is often a misconception by many outside of Regulatory Operations that document management is not important for regulatory affairs and electronic submissions because all of the documents used in regulatory submissions are approved long before they make it into a submission but that couldn’t be farther from the truth. Content generated by various functional areas such as clinical, pharmacology, toxicology, manufacturing and even marketing must all make their way through regulatory operations to be submitted to the appropriately agency for a particular product in order to gain approval.
It can be overwhelming when one contemplates the management of documents coming from multiple functional areas internally (new and revised) and multiply that by product, then by indication, by agency/country and you get a sense of why coordination and transparency can be critical. Many of those same documents have strict reporting requirements such as safety reports, periodic safety updates and annual reports, to name a few.
The ideal document management solution for regulatory operations will provide the following functionality:
OUR RESEARCH
BGM Pharmaceuticals Regulatory Affairs processes and procedures takes care of developmental planning, supervising, writing, reviewing. assembling and submission management to the governing body SAPHRA.
During our Regulatory Affairs process we give strategic and technical advice at the highest level, right from the beginning of the development of product incubation, thus making important contributions both commercially and scientifically to the success of a development programme and to our company as a whole.
In today’s competitive environment the reduction of the time taken to reach the market is vital to a product’s and hence the company’s success.
The proper conduct of its Regulatory Affairs activities is therefore of considerable economic significance for the company.
Inadequate reporting of data may prevent a timely positive evaluation of a marketing application. A new drug may have cost millions of rands to develop and even a three-month delay in bringing it to the market has considerable financial considerations. Even worse, failures to fully report all the available data or the release of product bearing incorrect labeling, may easily result in the need for a product recall.
A good Regulatory Affairs department will have a ‘right first time’ approach and will play a very important part in coordinating scientific endeavour with regulatory demands throughout the life of the product, helping to maximise the cost-effective use of the company’s resources. The Regulatory Affairs department is very often the first point of contact between the government authorities and the company. Officials respond much better to a company whose representatives are scientifically accurate and knowledgeable than to one in which these qualities are absent.
• Keep in touch with international legislation, guidelines and customer practices
• Keep up to the date with a company’s product range
• Ensure that a company’s products comply with the current regulations.
• The Regulatory Affairs professional’s job is to keep track of the ever-changing legislation in all the regions in which the company wishes to distribute its products. They also advise on the legal and scientific restraints and requirements, and collect, collate, and evaluate the scientific data that their research and development colleagues are generating.
• Formulate regulatory strategy for all appropriate regulatory submissions for domestic, international and/or contract projects.
• Coordinate, prepare and review all appropriate documents for example dossier and submit them to regulatory authorities within a specified time frame in conjugation with the organization.
• Prepare and review of SOPs related to RA. Review of BMR, MFR, change control and other relevant documents.
• Monitor the progress of all registration submission.
• Maintain approved applications and the record of registration fees paid against submission of DMF’s and other documents.
• Respond to queries as they arise, and ensure that registration/ approvalare granted without delay.
• Impart training to R&D, Pilot plant, ADl and RA. Team members on current regulatory requirements.
• Advising their companies on the regulatory aspects and climate that would affect proposed activities. i.e. describing the “regulatory climate” around issues such as the promotion of prescription drugs and Sarbanes-Oxley compliance.
• Manage review audit reports and compliance, regulatory and customer inspections.
• Regulatory Affairs professionals help the company avoid problems caused by badly kept records, inappropriate scientific thinking or poor presentation of data. In most product areas where regulatory requirements are imposed, restrictions are also placed upon the claims which can be made for the product on labelling or in advertising.
• Have a duty to provide physicians and other healthcare professionals with accurate and complete information about the quality, safety and effectiveness of the product.
• Authoritative
• Team Players
• Decisive
• Resourceful
• Skillfully Analytical
• Able to reapply scientific and regulatory principles
• Able to work with other disciplines
• Flexible and always willing to learn