Regulatory Consulting – Support across the regulatory life cycle

Regulatory requirements worldwide are continually evolving and differ from one country to another.

Clinexa provides its clients an experienced and cohesive regulatory, CMC and toxicology expert team with extensive experience of major regulatory agencies for drug and device clinical trials.

The regulatory and clinical teams have expertise in small molecule drugs, medical devices, vaccines, cellular therapies, immunotherapies, monoclonal antibodies, peptides and recombinant protein products.

Clinexa offers the following regulatory consulting support to clients:

Global regulatory intelligence with a detailed interpretation of global regulatory reform

Regulatory plan development

Clinical Trial Applications: CTAs/ INDs/ IMPD/Orphan drug designation (ODD), Paediatric Investigation plan (PIP), EU VHP support

Regulatory Documents Preparation (Country specific) including dossier compilation services for global (US – IND, NDA, ANDA, BLA, and Annual Reports; EMA – CTA, MAA, PSURs; Canada – NDS, ANDS, SNDS; Australia – MAA; GCC – MAA) and emerging markets (LATAM, APAC, and ROW)

Drug Master Files (DMFs)

Marketing Authorisation Preparation/ Revision

Scientific advice and Regulatory agency Interactions

Pharmacovigilance Regulatory Medical Writing

Act as QPPVA (Qualified Person responsible for Pharmacovigilance in Australia) and as a local contact person to interact with TGA

Clinical Trial Disclosures (Protocol registration and amendment maintenance on global clinical trial registries, redaction and anonymization of regulatory documents, authoring lay language summaries of clinical trial results, track requirements and compliance of global trial disclosure regulatory landscape)