Regulatory Agency Liasion
Every pharmaceutical company strives to establish a highly competent Regulatory Affairs (RA) team to successfully obtain and retain the approval for new pharmaceutical products. In this effort, Regulatory Affairs Liaisons manage the process of working with project teams to interpret global and regional regulatory requirements and prepare required documentation for timely submissions to agencies. Additionally, the Regulatory Affairs Liaisons play an important role to interact with the regulatory agencies to seek clarifications and provide responses to medical product related questions to health authority representatives.
We provide comprehensive regulatory agency liaison services to pharmaceutical and medical device companies to help navigate the complex regulatory landscape and ensure compliance with applicable regulations.
Our Capabilities
- Filing necessary applications and handling all government interactions pertaining to the regulation and certification process for a plant or other facility.
- Provide support as needed for routine Health Authority (HA) submissions including Annual Reports, New Protocol Submissions, Protocol Amendment, Renewal, Production Transfer (PT) Submissions (non-EU countries), New Product Planning (NPP) (non EU countries) etc. and as applicable act as main liaison with RA Operations to ensure accurate and timely submissions to HAs.
- Serve as the primary point of contact between your company and regulatory agencies to communicate and work with agency representatives to account for regulatory compliance.
- Provide guidance to internal stakeholders, such as product development teams, on regulatory requirements and expectations.
- Helps your organization stay up-to-date with all relevant regulatory requirements, including changes in regulations, guidelines, and industry standards, and advises the company on any necessary changes to maintain compliance.
How We Can Help
Our team of experienced regulatory professionals has the expertise to help you navigate the regulatory landscape and ensure compliance with applicable regulations. We work closely with you to understand your specific needs and develop customized solutions that meet your unique requirements.
Following are the key focus areas where our medical writing team has the expertise to deliver high-quality services throughout the drug / device development lifecycle as per applicable regulatory guidelines:
Handling Regulatory Submissions
Our experts can provide support as needed for routine Health Authority (HA) submissions including Annual Reports, New Protocol Submissions, Protocol Amendment, Renewal, Production Transfer (PT) Submissions (non-EU countries), New Product Planning (NPP) (non EU countries) etc. and as applicable act as main liaison with RA Operations to ensure accurate and timely submissions to HAs.
Support Product License Renewals
Our team can support in the planning, preparing and timely delivery of critical regulatory materials (registration samples) and various regulatory authorized documents (certificates) for product license renewals, manufacturing site transfers & new registration submissions in Most of the World (MoW)/Latin America & Canada & Region Europe (non EU countries) and Greater China regions (as per requirements).
Providing Regulatory Guidance to MAHs
Our experts can guide your team to timely submit various regulatory applications and obtain approval to achieve marketing authorization and life cycle maintenance in collaboration with following internal and external stakeholders. we interface with our clients' International Regulatory Affairs Team to support preparation of dossiers for registration for other international markets such as APAC, Japan, the Far East, Australia, and Latin America.
Contact us today to learn more about our regulatory agency liaison services and how we can help you ensure compliance with applicable regulations and achieve regulatory success for your pharmaceutical or medical device product.