Health authorities protect public health to the best of their abilities. They realise this by rigorously following the safety, stability, identity, purity, quality and potency of the products in the life science sector.
Our regulatory affairs experts ensure products comply with current good manufacturing practices, regulations and legal requirements. Pharmaceutical companies must observe strict rules and guidelines set by health authorities during all phases of product development to ensure the SQUIP-principle (safety, stability, identity, purity, quality and potency) of their products for patients.
Within this strictly regulated environment, our Regulatory Affairs consultants play an essential role:
- as a communication channel between the company and the health authorities involved;
- as a link between the various divisions within the company to offer support and act as a knowledge center;
- but also as a leading authority to provide strategic advice regarding extremely complex decisions during the life cycle of each product.
For this reason, our regulatory affairs managers are continuously working together with the authorities and the various divisions within their company to ensure complying with the current legal obligations as set by the health authorities.
The division Regulatory affairs also ensures obtaining and maintaining the marketing authorisations and controls activities, such as broadening the indication of medicine, changes of the formulation, changes in dosage, etc.
CHALLENGES RELATED TO REGULATORY AFFAIRS
The main challenge within each regulatory affairs department is the set-up of a solid, analytically driven strategy that is supported by the total organisation. Organisations which do not prioritise targeted and transparent strategic actions will not stand any chance when dealing with regulatory authorities. Successful observance of the valid regulations, which are becoming increasingly more strict, requires a systemic thinking process and a systematic approach, based on the effective use of strategic insight, group mobilisation and cooperation with the public authorities, lobby groups and regulators.
Furthermore, regulations within the pharmaceutical sector are continuously changing due to harmonisation, safety and security issues, globalisation and acquisitions. Pharmaceutical companies must make a constant effort to closely follow these changes and to reorganise in a flexible manner if they are expected to do so.
The medical and pharmaceutical community consists of a broad network of stakeholders. Our medical affairs experts play a crucial role within this network as business ambassadors who build relationships and facilitate information exchange.
Over the years, public authorities and other regulatory authorities have urged pharmaceutical and medical companies to set up a department which is separate from their commercial activities. As a result, the medical affairs department has acquired the important role of being the medical face of these companies. Our Medical affairs officers are closely connected with the pharmaceutical and medical community, understand the challenges facing the sector and proactively search for solutions:
- they manage relationships with key stakeholders, including medical experts and thought leaders;
- they process data and publish clinical trial reports;
- they collect important data and insights related to product development;
- they work on research initiatives outside labeled and marketed indications;
- they distribute educational information;
- they provide information concerning the safety of products for healthcare professionals, such as doctors, pharmacists and nurses, and for patients.
How can our regulatory and medical affairs officers help you?
Our regulatory affairs officers & managers have extensive experience in the field of national and international audits, regulatory strategies, market authorisation applications and communication with the authorities. They would be pleased to assist you with:
- the development of regulatory strategies for product life cycles;
- the preparation, submission and approval of drug product dossiers;
- the evaluation, archiving, preparation, revision and submission of market authorisation applications;
- the improvement of the interaction with the authorities.
Our regulatory affairs managers ensure that all your dossiers, registrations and authorisations are submitted in time and that all safety-related changes are implemented in time. Furthermore, they ensure that all projects will progress in accordance with the current SOPs and guidelines.
They are accustomed to work in teams and to closely interact with and consult other divisions, including colleagues from the divisions: production, business development, pharmacovigilance, product launch, artwork, supply chain and quality, to ensure conformity on the level of your organisation.