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REGULATORY SERVICES

ALS offers a wide range of regulatory service by our dedicated Regulatory Affairs Department, which includes assistance with marketing authorization applications (MAA), as well as renewals, documentation required for registration, and preparation of labeling.

We view the Regulatory Affairs team as a pathway to new markets. Increasing investment in this team has resulted in a greater number of product registrations across the globe, thus acting as a catalyst for growth. The Regulatory Affairs team plays a crucial role in the company and is involved in all stages of drug development and also after drug approval and marketing. Externally it is the key interface between the company and the regulatory authorities.

We have an experienced and capable team that guides drug development strategy in today’s endlessly evolving pharmaceutical landscape. Our team consists of experienced pharmacist involved in integrating regulatory principles, preparing and submitting relevant regulatory dossiers to health authorities. They keep a close eye on the ever-changing regulatory guidelines to ensure our procedures and documents are compliant with country-specific guidelines.

Regulatory Affairs is involved in the development of new medicinal products from early on, by integrating regulatory principles and by preparing and submitting the relevant regulatory dossiers to health authorities. Regulatory Affairs is actively involved in every stage of development of a new medicine and in the post-marketing activities with authorized medicinal products.

Regulatory Affairs ensures that the information and data to be conveyed and discussed with the regulatory bodies are presented in the right way and form. Regulatory Affairs contributes essentially to the overall success of drug development, both at early pre-marketing stages and at all times post-marketing. Regulatory Affairs plays a key role in guiding drug development strategy in an increasingly global environment.