Before starting to market a medicine in foreign country, there is a need to undergo a registration process to check its safety, efficacy and/or quality.
Our regulatory affairs team has the expertise, long-term experience preparing and compiling the registration dossiers for all categories of healthcare products in line with the latest regulatory requirements in multiple countries before submitting them to the appropriate health authorities. We register Pharmaceuticals, Generics, Innovator Drugs, CRO, CMO, Biologics, Biosimilars, Vaccines, Over-the-Counter Drugs, New Chemical Entity/New Molecule Entity (NCE/NME), Generic- Prescription, Generic- OTC, Biologics, Biosimilar, Vaccines, Orphan Drug, Traditional Medicines, API, Excipients and so on.
Barrco Regulatory Solutions with teams of local experts can develop the appropriate regularly intelligence, strategy and pathway for the registration of your healthcare products in different markets.
Our main goal is to ensure that your medicines comply with the Health Authorities standards to guarantee quick registration at the national medicines registry as well as successful marketing by giving a comprehensive response to a variety of regulatory challenges during the lifecycle of your medicines.
Over the past 20 years, we have gained extensive regulatory and registration experience in Latin America, Asia, Russia/CIS, the US, Middle East, and Europe. We worked in various segments such as Pharma/Rx, Consumer health, MD, FS, Cosmetics, etc.
The devoted staff of Barrco Regulatory Solutions offer you the following solutions in order to comply with the stringent requirements of the Health Authorities. We obtain approvals that will enable you to quickly market your medicines and to handle the maintenance of marketing approvals (licenses) in the best manner:
– Regularly or temporarily filling the role of Appointed Pharmacists.
– Submitting a detailed registration dossier and samples in order to obtain a registration certificate and license for marketing a new medicine (ethical, generic, bio-similar).
– On-going Monitoring and reporting of variations in the registration status and the registration file during the life cycle of the medicine.
– Coordinating the leaflets and artworks to the registrations conditions and updating them when required.
– Deep familiarity with regulations and registration procedures and keeping up to date with on-going changes.
– Reporting to the authorities, medical staff and the public as well as taking immediate measures if suspicious that the quality, safety or efficacy of the medicine may have been harmed.
– Receiving approval from the Health Authorities for any promotional material intended for the public.
– Performing marketing activities for the target audience of the medical staff according to the registration conditions that were set by the regulator.
– Receiving an annual import approval for the marketing of registered medicines.
– Efficient and professional support after the above mentioned activities up to obtaining the approval from the Health Authorities.
– Ensuring regular supply and taking necessary measures in cases where the availability of the medicine is doubt.
– Handling import permits for marketed medicines, samples for registration and raw materials.
– Review and submission of promotional materials to the Health Authorities for approval.
Due to the diligence, professionalism, creativity and the close working relationship with the authorities, the customers of our company have increased the amount of medicines registered which has led to a growth in their business activities.
In a lot of countries, the documents need to submit not in English, but in their native languages. For example- in Russia and Russian speaking countries, some Asian countries like China, South Korea, Japan ect, American countries like Brazil, Mexico ect and most European countries. Our translation team can translate the full dossier, and make the dossier as per local requirement.
