Development Regulatory Affairs

 

Have you chosen the right indication and dose for your product? Is your documentation fit and ready for submission?

Reliable regulatory expertise and robust authority liaison experience from early development and onwards are essential factors for the commercial success of any pharmaceutical project. The regulations and requirements of today will not be the same in just a few years’ time. Sofus has a unique competence in creating innovative regulatory strategies for all phases of the pharma development.

 

Bridging regulators and science

The regulatory landscape of pharmaceutical and biological products is ever-changing, constantly growing and increasingly demanding. How to manoeuvre through this landscape in the most efficient and reliable way is a science topic in itself, and requires extensive knowledge coupled with hands-on experience and skills.

Our development group consist of experts in CMC (Chemistry, Manufacturing & Control), non-clinical, clinical, and pharmacokinetics (PK/PD), with knowledge and experiences that complete each other. We are experienced in giving strategic regulatory guidance and independent advice, including assistance when preparing questions, briefing documents and follow-ups of scientific advice meetings with EMA, local competent authorities and FDA.

From pre-clinic to formulation development

Our services cover the development phase, from preclinical development including guidelines and study design, to clinical study protocol development, preparing of CTAs (IMPDs, INDs, IBs), CT authorisation submission including VHP for EU-countries, and management Paediatric investigation plans (PIP), to guidance with respect to regulatory CMC requirements for both process development (drug substance) and formulation development (drug product), including technology transfer.

EU registration dossier experts

The EU registration dossier is of course close to our heart. We perform both due diligence and GAP-analysis of existing dossiers, as well as compile new full applications for pharmaceutical medicinal products, biologics and biotech products, hybrids, generics, biosimilars, and orphan drugs (including Orphan Drug Designation applications and annual updates). This means that we write dossier sections and modules, especially the summaries and overviews.

Additional services are writing of annual safety update reports, Risk Management Plans (RMP) and Environmental Risk Assessments (ERA), and assistance regarding the requirements for information for product information and labelling (SPC, PIL).

Our experienced consultants offer a complete scope of services

Our consultants are ex-Medical Products Agency/EMA and HTA authority reviewers with extensive experience, spanning from large international to small pharma and research companies. In addition to regulatory competence, our consultants have the necessary scientific experience from preclinical- and early clinical phase projects to post-approval variations. They have worked with human as well as veterinary products, small molecules and biologicals, advanced therapy and medical devices, allowing a complete scope of services throughout the product life cycle.

 

Contact a specialist:

Erik Hedner

Erik Hedner
Director Development Regulatory Affairs
Phone: +46 8 5600 2008
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