REGULATORY Services

We provide professional Regulatory Affairs expertise and support to help businesses navigate the complex world of regulatory compliance, ensuring their products or services meet legal and safety standards across different markets.

Our main service areas are:

1. Regulatory submission: 

Preparing and submitting documentation required to gain marketing approval for Generics Formulations and APIs on worldwide markets. Main area of expertise on Europe.

2. Lifecycle management: 

Overseeing the entire lifecycle of the product from early development through post-marketing variations to ensure ongoing compliance.

3. Strategy of regulatory submission: 

We advise where different submissions should happen and what needs to be done to make it possible and fastest. We identify and keep track of relevant regulations that could affect your business in different markets. 

We determine the regulatory pathway for entering new markets, including documentation, testing, and certifications needed to launch in those regions. 

We identify potential regulatory risks and develop strategies to minimize them and ensure smooth launch of the product. 

We also engage in communication with regulatory authorities and stakeholders, ensuring transparent communication, and eventually advocating for policy changes when necessary.

4. Compliance and Safety: 

Ensuring that all pharmaceutical products meet safety standards before reaching the market.

5. Accelerated Approval Pathways: 

Explore options for accelerated approval pathways, which can expedite the review process for qualifying products.

6. Regulatory Intelligence and Updates: 

Providing insights into changing regulations, industry standards, and best practices, ensuring businesses stay ahead of compliance requirements. Keep companies informed about changes in relevant laws, regulations, and guidelines.

7. Global Regulatory Coordination: 

Helping businesses navigate the challenges of obtaining approval in multiple regions (e.g., U.S., EU, Latam, Asia), ensuring that regional differences in regulatory approaches are managed in optimal way.