REGULATORY AFFAIRS DEPARTMENT
In a strictly controlled and highly regulated pharmaceutical sector, the role of Regulatory Affairs is becoming critical with every passing day. The department acts as the interface between company and government authorities.
Our regulatory affairs’ professionals keep track of the ever-changing legislation relevant to our company’s products, advice on the legal and scientific restraints and requirements, and collect, collate and evaluate scientific data. Coordinate, prepare and review all appropriate documents for example dossier and submit them to regulatory authorities within a specified time frame. Monitor the progress of all registration submission. Manage review audit reports, compliance and regulatory inspections. Our goal is to protect human health, ensuring safety, efficacy, and quality of drugs, ensuring appropriateness and accuracy of product information.
MEDICAL AFFAIRS DEPARTMENT
We have a well-established Medical department. The healthcare and well-being of patients are the first priority at BHP - as our corporate slogan is ‘Health is Our Concern.’ We ensure that all external interactions are ethical, appropriate and must adhere to the BHP Policy of External Interaction. Our medical policies are driven by International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) code of practice and the applicable local rules and regulations in place including the Drug Act 1976 and DRAP 2012 which sets out BHP’s adherence to the high standards of business integrity while keeping in line with the constantly updating guidelines from our international partners Astra Zeneca, Allergan and Astellas. We ensure continued compliance with all applicable laws and regulations by laying down the key principles and compliance standards applicable to specific sales and marketing activities within Pakistan. We provide medical trainings to our marketing and sales team.
Pharmacovigilance system at BHP ensures that any untoward effect occurring in connection with the administration of any of the Barrett Hodgson Pakistan (Pvt) Ltd. products is identified, promptly collected and then analyzed by experts and appropriately disseminated to contribute to making drug administration safer and to prevent occurrence of adverse reactions. We are committed to inculcate Good Pharmacovigilance practices for the sake of medical fraternity and public, and are dedicated to improve patient care and safety for the betterment of Pakistani society at large.