Regulatory Services

Our services are integrated and focused on the specific needs of the Life Science and Healthcare markets. We offer real help that will allow you to satisfy all regulatory requirements and optimise your cold chain.

Based upon a long experience in the highly-regulated pharmaceutical, biotechnological, medical and healthcare sectors, Alternatives Technologie Pharma has developed significant regulatory skills based on the norms of Health Canada, the EMEA and the US-FDA.

Cold Chain Process Analysis

The regulatory gap analysis will allow you to recognize the governmental requirements relative to the cold chain for various countries you do business with. Although the modern tendency is to standardize these requirements towards increased cold chain control, knowing the stakes and current regulations will allow you to make the necessary efforts to satisfy these requirements and to get better results when regulatory audits are performed.

The risk analysis allows us to set critical parameters for the implementation of the cold chain management systems and solutions, not to mention to upgrade the level of regulatory compliance. The analysis is done on product profile, product stability, transport procedures, primary and secondary packaging, documentation management and component specifications, design, and qualification of installation, operation and performance (IQ, OQ, PQ).

A complete cold chain analysis is a step that will help you identify all the parameters that can impact the quality of your products. This analysis is a key step that will allow you to take on optimisation work.

Mapping, Validation and Qualification

We offer mapping services for your storage rooms, warehouses and other thermal equipment. Alternatives Technologie Pharma also offers validation and qualification services for all equipment involved during the development and manufacturing of sensitive products, and particularly for the equipment used in the Life Science sector and for the thermal equipment.

The validation/qualification includes written installation, operational and performance protocols (IQ, OQ, PQ), the carrying out of these protocols and written reports.

Regulatory Support, Training and Documentation

You will be able to use our editing services when necessary to develop standardized operations policies and procedures (PNP, SOP) concerning your cold chain. Our specialists will help you upgrade these policies and procedures and will take charge of the implementation of your complete cold chain policies.

We can also perform internal quality audits for you in your production and storage departments as well as perform external quality audits at your transport supplier to ensure your policies and procedures are being followed. Finally, we also perform personnel training on regulatory and cold chain aspects.