Regulatory Affairs and Market Access Services
In the dynamic world of life sciences, ensuring regulatory compliance and gaining market access for your products is essential for success. Our team of experienced regulatory experts and market access specialists is dedicated to helping you navigate the complex regulatory landscape and bring your innovative products to market.
Our Services:
- Regulatory Strategy Development:
- Tailored regulatory strategies to address specific market needs and requirements.
- Guidance on regulatory pathways and submission requirements.
- Representation at regulatory agency meetings.
- Regulatory Submissions:
- Preparation and submission of regulatory dossiers for drug, biologic, and medical device products.
- Management of regulatory submissions and interactions with regulatory authorities.
- Post-Approval Activities:
- Post-marketing surveillance and vigilance.
- Label changes and line extensions.
- Periodic safety update reports (PSURs).
- Market Access:
- Health technology assessments (HTAs).
- Reimbursement strategies and negotiations.
- Pricing and market launch planning.
- Patient access programs.
- Regulatory Compliance:
- Gap analysis and remediation.
- Internal audits and inspections.
- Training and education on regulatory requirements.
Why Choose Us:
- Deep Regulatory Expertise: Our team has extensive experience in navigating global regulatory landscapes and understanding the unique requirements of different markets.
- Customized Solutions: We tailor our services to meet your specific needs and objectives.
- Proven Track Record: Our successful track record of helping clients achieve regulatory approval and market access.
- Collaborative Approach: We work closely with our clients to build strong partnerships and ensure their success.
Let us help you navigate the complex regulatory landscape and achieve your market access goals.
- Technical file evaluation and compilation
- Conformity assessment and lifecycle management
- Clinical evidence and design examination
- Medicines and medical devices, biologicals, gene and cell therapies, ATMPs
- Orbis/ACCESS/Orphan/Provisional/Priority and other expedited pathways
- Regulatory agency meeting facilitation USA, EU, UK, CH, AU, JP ++
- Risk Management Plans and drafting of product information
- Regulatory due diligence
- Regulatory dossier writing, compilation and ePublishing
- Evaluation support and product lifecycle maintenance
- Pricing, market access and reimbursement submissions
We are committed to the success of your products and to help you develop and implement regulatory and quality solutions catered to your needs.
Our team of consultants bring many years of combined experience in Regulatory Affairs, Compliance and Quality Assurance, working with regulatory bodies around the world such as the TGA, Medsafe, FDA, EU Competent Authorities and Notified Bodies, and various global Authorized Representatives with a proven track record of executing techniques in a timely and cost efficient manner.