Registration
At PharmaConsilum we offer a complete suite of Regulatory Affairs services designed to streamline the compliance journey for our valued clients. Whether you're looking to submit documentation for locally registered or pending products, or you need assistance with regulatory compliance, we've got you covered.
Our Services:
- End-to-End Regulatory Solutions
- Our team delivers fully prepared documentation for regulatory submissions.
- Ensuring your products meet local and international regulatory standards.
- In-House Regulatory Partnership
- We serve as your in-house regulatory partner for markets around the globe.
- Streamlining your path to national regulatory compliance in specific countries in accordance with your company policy.
- Prior Regulatory Activities
- We assist with the pre-submission process, ensuring your documentation is comprehensive and in alignment with regulations.
- Post-Regulatory Activities
- Ongoing support post-submission to ensure compliance is maintained and any necessary adjustments are made.
PharmaConsilium is your trusted partner for navigating the complex landscape of regulatory affairs. Our end-to-end services are designed to provide peace of mind and allow you to focus on what you do best: innovating and growing your business. We look forward to assisting you on your regulatory journey.
Scope of our services includes:
- Registration
- Variation
- MAH transfer
- Providing on time information about local regulatory requirements
- Answering to request from local authorities
- Support during audits
- Support during planning implementation of changes that have local impact.
- Packaging validation
- Publishing dossier
