Regulatory Affairs Consultation for Life Sciences and MedTech

The regulatory environment is fast changing fuelled by digital transformation, and AI-driven tools integration. In this volatile situation, in addition to focusing on developing innovative therapies and life-saving drugs, being agile in decoding ever-changing global regulatory frameworks could be challenging for pharma and MedTech manufacturers. Large pharma manufacturers majorly outsource their regulatory operations to experts outside the organizations. Despite the critical importance of regulatory compliance and the threat to data safety, they do opt for external regulatory service providers due to several strategic and operational reasons.

At Vigilare, with up-to-date intelligence on global and local regulatory requirements, we streamline regulatory operations from strategy design to submission process with extended support for post-approval product lifecycle management. It helps organizations to stay ahead in complex Regulatory environments, mitigate risks, and prepare for compliant regulatory submissions, confident health authority interactions and reduce overall time-to-market.

Vigilare’s Regulatory Affairs Consultation Expertise

Regulatory Intelligence

With specialized teams spread across 100+ countries, Vigilare’s regulatory affairs consultants decode local regulatory requirements and strategically leverage them for a global market entry approach. We monitor regulatory changes across global health authorities (US FDA, EMA, TGA, MHRA, CDSCO, etc.,) and provide actionable insights with a strategic foresight. We assist Life Sciences and MedTech organizations navigate the complex Regulatory landscape with Market Intelligence across geographies, Product Classification & Assessment, Product Registration Norms, Legal Compliance,

Regulatory Landscape Assessment, Government Affairs, Regulatory and Clinical Documentation,

Launch Strategy, and Cost-effectiveness Analysis.

Submission Strategy and Dossier Development

Adoption of eCTD 4.0 to integrate AI methodologies, real world evidence, data security, etc., regulatory submission templates are rapidly evolving. Amidst, preparing your dossier with utmost clarity, and consistency for streamlined review can be challenging without real-time knowledge of the updated templates. At Vigilare, with accurate insights on the submission guidelines and templates, our regulatory affairs consultants align your submission documents, CTD/eCTD, 510(k) or PMA, etc. irrespective of the industry – Pharmaceuticals, Biologics, and/or Medical Devices.

Regulatory Gap Analysis and Risk Management

At Vigilare, we conduct in-depth gap analysis on current processes, policies, and documentation against those regulatory requirements mandated by global health authorities. Vigilare’s regulatory affairs consultants identify deficiencies and discrepancies to reduce the risk of non-compliance. We also identify, and evaluate the potential operational and procedural risks from the gaps found and mitigate them on time for successful product compliance and timely market access.

Labeling, Claims & Advertising Compliance

Global health authorities are mandating and adopting the zero-tolerance approach to misinformation. It means organizations must ensure that every aspect of the product communication is accurate and must protect patient safety as per the health authority standards to avoid expensive enforcement actions. Vigilare’s regulatory affairs consultants ensure labeling, claims, and advertising materials are compliant starting from compilation to review.

Health Authority Interactions and Meeting Support

Throughout a product’s development and approval life cycle, there are many times that Life Sciences/MedTech organizations and regulatory agencies interact with each other referring to data clarifications, concern addressals, etc. These could be Pre-IND, End-of-Phase, Pre-NDA/BLA, and Advisory meetings. Vigilare’s regulatory affairs consultants lead the HA meetings, assisting organizations with strategic planning, regulatory guidance, data dissemination, and preparatory or brief sessions.

Facts to Focus

Labels Processed

0 K

North American Submissions

0 K

Applications Delivered

0 +BLA

MICC Calls Handled

0 K+

Testimonials

Partnering with Vigilare for pharmacovigilance services has been a game-changer. Their team is proactive, detail-oriented, and consistently on top of safety updates and regulatory changes across Europe. It’s rare to find such a dependable partner who treats compliance as seriously as we do.

We rely on Vigilare for global pharmacovigilance support across multiple regions. They understand the nuances of each market and consistently deliver accurate, timely, and compliant safety reporting. It’s been a relief having such a competent team on board.

Vigilare’s post-marketing support has helped us maintain compliance seamlessly in the US market. Their responsiveness and structured reporting systems made it easy to keep pace with regulatory expectations. Their clarity and ownership stand out.

We engaged Vigilare during a critical vaccine rollout phase. Their insights into regulatory processes in the Middle East, combined with their ability to coordinate across regions, ensured smooth approvals and timely submissions. They truly acted like an extension of our team.

Vigilare has been instrumental in supporting our medical device registrations in both the US and European markets. From preparing the technical documentation to navigating CE and FDA submissions, their expertise made a complex process feel manageable and well-guided.