Regulatory Support & Submissions

Full strategic support and product development expertise in all stages of the drug development process.

Here at Lane Head Clinical Consultancy, we offer full strategic support and product development expertise in all stages of the drug development process.

Our regulatory affairs consultants understand that you need an experienced professional who thoroughly understands both your product and the relevant regulatory process, and who can work with you and your team throughout the product lifecycle. Our frequent interactions with both national and international regulatory agencies can provide invaluable insight for your development projects.

In addition, our long-term client relationships and high rate of repeat business reflect our expertise and commitment. We work with a global network of experts and are highly experienced in interpreting regulations and guidelines with over 30 years’ worth of combined experience working for pharmaceutical and medical device companies. By sharing our knowledge across projects, we can maximise efficiency to offer you high-quality solutions in order to help make your goals a reality.

Our regulatory consulting services include:

• Consulting services on drugs, biologics, and device development regulatory requirements
• Acting as a regulatory consultant for companies
• Preparation and review of clinical protocols, amendments, and response to agency questions
• Publishing and document management experience, including new drug applications, marketing authorisation applications, and submissions
• Experience of the eCTD submission process.

We also support trial design, regulatory submission, and compliance from Phase 1 right through post-marketing, and we have extensive experience preparing customers for major submissions and agency meetings, and can assist in developing:

• Strategic development plans
• Investigational New Drug (IND) preparation and submissions
• Study design
• Clinical Study Reports (CSRs).

Our regulatory affairs consultants also collaborate with our medical writers to prepare high-quality documents such as:

• New Drug Applications (NDA)
• Global ethics submissions
• Paediatric Investigation Plans (PIPs)
• Periodic Safety Update Reports (PSURs)
• Risk Management Plans (RMP)
• Preparation to support Marketing Application Approval (MAA) phase, or during the post-marketing phase.

Contact our team today.

If you’d like more information about our Medical Writing capabilities, please take a look here. Or, if you’d like to speak with us about any of our services, please make an inquiry using the contact details on the main page of our website.

We look forward to working with you,

The Lane Head team.