Regulatory Affairs

To align with our client’s research goals and objectives our team develop regulatory strategy and planning. We are capable of identifying the most efficient pathway to prepare and submit regulatory applications in compliance with relevant regulations and guidelines.

Abiogenesis Clinpharm collaborate with clients to design and develop study protocols that comply to regulatory requirements ensuring the well-being and safety of participants. Our team review protocols to ensure accuracy, completeness and adherence to GCP and regulatory guidelines.

Our experts prepare and submit regulatory applications such as IND, ANDA and USFDA and others to various regulatory agencies across the world. We ensure that our expertise facilitates effective review and approval process to meet regulatory requirements.

At Abiogenesis Clinpharm, our team is dedicated to provide comprehensive pharmacovigilance and safety reporting services to ensure compliance with global safety reporting regulations minimizing adverse events and improving patient safety.

Our team designs plans and strategies, examines regulatory requirements and guidelines, implements compliance measures and offer training and support on regulatory compliance. We determine and assess risks, draw strategies for risk management, implement risk mitigation techniques and continuously track and update risk management plans.

At Abiogenesis Clinpharm, our Regulatory Affairs team prepares for regulatory inspection and audits for clients to identify compliance gaps and develop strategies for them. To ensure compliance with relevant regulations and guidelines, our team prepares Standard Operating Procedures and training program maintaining the highest level of regulatory integrity.

Our team understands the significance of effective communication with regulatory agencies and offer comprehensive services support in regulatory correspondence, regulatory agency meetings and submissions and inspections. At Abiogenesis Clinpharm, we ensure that our communication are in compliance with regulatory requirements  building a strong and long term relationship with clients and  regulatory agencies.

At Abiogenesis Clinpharm, our regulatory affairs team play a crucial role as competent intermediary with regulatory authorities. We provide high level support and guide clients through the complex regulatory landscape. Our team is committed to a clear and transparent communication and promptly addressing any inquiry or challenges that may arise for a smooth and successful partnership.

Our Regulatory Affairs team offer services for preparing and submitting clinical trial applications (CTAs) to regulatory bodies. Our team prepare study design and protocol development, informed consents, case report forms, clinical trial protocols for submission of CTAs to regulatory agencies.

Our Regulatory Affairs team has the experience and cultural understanding on navigating the regulatory nuances ensuring that the regulatory submissions are in compliance with the regulatory standards. At Abiogenesis Clinpharm, our team excels in interpreting complex regulatory specifications across different countries into clear and implementable guidance for clinical development ensuring global compliance.

At Abiogenesis Clinpharm, our regulatory experts are committed to support clients throughout the product life cycle and beyond the approval process. Our team support post approval services including post marketing study, safety monitoring and pharmacovigilance. Our team ensures that our client’s product are in compliant, safe and effective for long term success.