Regulatory Science & Product Development Experts helping customers
Commercialise Products | Reduce Time to Market | Achieve Compliance | Grow Business
One of the key strategic success factors in product and product development activity approvals is the selection of an effective, efficient, optimized and most promising regulatory and product development approval strategy with the best risk-value profile from both commercial and scientific perspective.
Quite often, companies are unaware that they have more options at their disposal due to local regulatory nuances and non-availability of geography specific product intelligence. The decision then, on how to strategise, structure, prioritise, develop and implement the project approval process is dependent on a variety of unknown or partially known factors.
Vyomus Consulting regulatory practitioners help you analyse your specific project, create a product specific regulatory intelligence process document, help you fully understand the regulatory environment, develop optimized product and product development approval strategies and roadmaps taking into account precedents, current regulatory thinking and the regulator’s way of interpretation. In close co-operation with your team, we develop and implement the specific strategies and road maps that apply to your project.
This regulatory, product and product development specific strategies and road maps help you achieve faster product approvals leading to enhanced access to Markets and Opportunities.
Our experienced, senior regulatory professionals provide Regulatory and Product Development expertise through all stages of the product commercialisation lifecycle to enhance regulatory submission preparation and achieve faster regulatory, business outcomes, leading to enhanced access to Markets and Opportunities.
Integrating Science, Regulations, Measurable Business outcomes and combining local knowledge with global standards, we move beyond providing expert advice to get your project off the ground, move at a fast pace and achieve faster approvals.
Our overall experience includes over six hundred preclinical, clinical trial approvals, product registrations, marketing authorizations, import and marketing authorizations, manufacturing and marketing authorization and transactions covering a large number of therapeutic and product categories.
- Scientific Assessment, Regulatory Assessment, Regulatory Intelligence, Product Development Plans, Regulatory Roadmaps, Regulatory Strategy, Risk & Mitigation Plans.
- Construct local &global regulatory strategy including:Research appropriate end-points that are acceptable for different countries, Research past precedence for development of regulatory strategy, Therapeutic Area Analysis, Conduct Gap Analysis for Product approvability or IND acceptability, Create Regulatory Development Plans, Create Draft Package Insert or Target Product Profiles.
- Market Authorisations, Clinical Study Approvals, New Drug Approval, Labelling Services, Regulatory Strategy, Regulatory Reporting, Regulatory Submissions, Regulatory Intelligence, Authorised Agent Services, Market Access.