With the right support, your regulatory documentation will run more smoothly and comply with regulatory requirements and your organisation’s demands. This should ensure documentation is prepared, submitted and stored in a compliant manner.
Regulatory documentation includes applications, registrations, variations, approvals; correspondence with and, responses and reports provided to, health authorities; supporting documents and data relating to a drug product.
Preparing, authoring, reviewing and approving regulatory documents can be a challenge. To ensure a successful and efficient global regulatory submission, multiple teams across several locations and departments will need to cooperate. Once the documents have been submitted, they will also need to be tracked and archived correctly.
Arex Advisor can help pharmaceutical and biotech companies with documentation management in many different systems and in many stages of development.
We are flexible, and our consultants can handle and take responsibility for a specific regulatory document or be part of a client´s organisation and take a more active role in coordinating the regulatory team and ensuring that the regulatory documentation is prepared, submitted and stored according to regulatory requirements.
Documentation management is often combined with our other services such as lifecycle management, regulatory strategy, medical writing, quality assurance and CMC project management.
Lifecycle management
Regulatory project management
Product information services
Erik Hedner
Arex Advisor AB
Contact us
Staffan Thunell
Founding partner
BSc Economics and BA
Staffan has a long background in entrepreneurship within the life science industry. He has 20+ years experience from positions as Founder, Chairman, CEO and CFO within medical affairs consulting and small pharma. Previously Staffan worked in executive positions in big pharma and specialty pharma companies.