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 25 countries (APAC, LATAM, MEA, Eurasia, EU, Central & Eastern Europe).