Regulatory Approval Consulting
At Celero, we provide biotech firms with expert guidance on regulatory compliance, addressing challenges and ensuring seamless navigation through necessary procedures.
Regulatory Affairs Services for Biotech Innovators.
Celero is your trusted partner for regulatory affairs service, encompassing strategic guidance, compliance expertise, and streamlined navigation through all essential regulatory protocols and procedures.
CTD Documentation
Expert preparation of full Common Technical Document (CTD) for pharmaceuticals & biologicals.
Clinical Expert Review
Proficient review for the clinical & non-clinical modules of the CTD.
M4 & M5 Preparation
Streamlined creation and management of essential regulatory documents.
Medical Device Technical File
Comprehensive preparation tailored for medical device regulations.
Authority Communication
Proficiently responding to comments from competent regulatory authorities, ensuring a smooth approval process.
Bioequivalence Protocol
Expert preparation and review tailored to the highest standards.
Literature Screening
Rigorous examination of scientific literature relevant to your product.
Product Information Management
Crafting and updating essential product information such as SmPC, PIL, IB, and labelling.
Herbal Medicines
Specialised preparation of scientific files tailored for herbal treatments.
Post-Approval Maintenance
Vigilant upkeep and updates post product approval.
Third-Party Bioequivalence Center Audits
Ensuring third-party centers align with all regulatory standards.
Global Coverage
Celero Executive team have experience in 80 trials across multiple clinical development phases (P1-P4) in more than 29 countries (US, EU, LATAM, APAC and Africa).
Introducing the Celero Way
A pathway to high-quality, cost-controlled, accelerated trials tailored to your needs.
Learn more about The Celero Way or speak to our Regulatory Approval expert.
