Regulatory Studies and Assessments

Regulatory Studies and Assessments

Ensuring Quality, Equivalence, and Stability of Pharmaceutical Products

At Saba Regulatory, we offer a range of regulatory studies and assessments to ensure the quality, equivalence, and stability of pharmaceutical products. Our expert team conducts various studies and evaluations, providing comprehensive data and insights to support regulatory compliance and product success.

Trust Saba Regulatory for your regulatory studies and assessments needs. We are committed to supporting our clients in meeting regulatory requirements, achieving product excellence, and ensuring patient safety.

BE Study (Bioequivalence Study)

Bioequivalence studies are essential for demonstrating the equivalence of generic drugs with their reference products. Our team conducts rigorous bioequivalence studies following international guidelines and regulations. Through careful design, sample collection, and statistical analysis, we generate reliable data to support the registration and approval of generic pharmaceutical products.

Key highlights of our BE study services include:

Study Design and Protocol Development

Our experts work closely with clients to develop study designs and protocols that meet regulatory requirements. We ensure that all necessary parameters and endpoints are considered to establish bioequivalence effectively.

Subject Recruitment and Sample Analysis

We oversee subject recruitment and conduct thorough sample analysis using validated methods and state-of-the-art equipment. Our team adheres to strict quality control measures to ensure accurate and reliable results.

Comparative Dissolution Profile

Comparative dissolution profile studies are conducted to assess the dissolution characteristics of drug products. These studies help evaluate the release of active pharmaceutical ingredients from different formulations or generic drugs compared to their reference products. Our team performs comprehensive dissolution profile evaluations following recognized guidelines and regulatory standards.

Key highlights of our comparative dissolution profile services include:

Method Development and Validation

We develop and validate dissolution methods specific to the drug product under evaluation. Our experts ensure that the methods are robust, accurate, and precise, enabling reliable comparisons between different formulations.

Dissolution Profile Evaluation

Our team analyzes dissolution profiles and generates data to assess the release characteristics of drug products. We provide comprehensive reports with in-depth analysis and interpretations, aiding in regulatory submissions and compliance.

Stability Study

Stability studies play a crucial role in evaluating the shelf-life and storage conditions of pharmaceutical products. Our team conducts comprehensive stability studies to assess product quality, efficacy, and safety under various storage conditions over an extended period. These studies provide essential data for determining appropriate shelf-life and storage recommendations.

Key highlights of our stability study services include:

Study Design and Testing

We develop robust stability study protocols tailored to the specific product, considering relevant regulatory guidelines. Our team conducts comprehensive testing, including physical, chemical, and microbiological analyses, to evaluate product stability.

Data Analysis and Shelf-Life Determination

Our experts analyze stability study data to determine the shelf-life and storage conditions of pharmaceutical products. We provide detailed reports with clear recommendations, ensuring compliance with regulatory requirements.