Regulatory strategies to help you navigate the complexities of drug development.
Starting with the end in mind, from a Target Product Profile and Clinical Development Plan to interactions with Regulatory Agencies worldwide to support regulatory filings, we provide collaborative consulting to enable our clients to achieve their commercial goals in the most expeditious way.
Avoid obstacles on the regulatory path, reduce unnecessary delays during product development and maximize patent life.
Successfully achieve your commercial goals faster. Avilez Rocha Consulting works to ensure that your regulatory needs are met intelligently, accurately, and efficiently.
Definition of regulatory strategies for drug development, with a special focus on neuroscience (neurology, psychiatry, pain).
Consultations and negotiations with regulatory agencies, including FDA (USA), EMA (European Union), Anvisa (Brazil), Health Canada (Canada), MHRA (United Kingdom), and PMDA (Japan).
Scientific evaluation of projects and due diligence for strategic decisions in funding, awards, and business.
Education and training in drug development and public engagements at scientific forums.
Evaluation of the abuse potential of drugs in development, ensuring regulatory compliance and risk mitigation.
Deep knowledge, extensive experience and proven records.
With over 35 years of experience in academia, government, and industry in Brazil, France, and in the United States, Dr. Beatriz Rocha, founder of Avilez Rocha Consulting, is a renowned expert in drug development and global regulatory strategy, helping companies navigate the complex regulatory landscape towards achieving their commercial goals in the most expeditious way.
Highlights of her career:
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Medical Doctorate from the Federal University of Rio de Janeiro (UFRJ), with specialization in anesthesia and pain management.
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PhD in Behavioral Pharmacology from the University of Strasbourg (France).
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Over more than 20 years of experience in Regulatory Affairs, at Merck Research Laboratories, Covance, Labcorp, and Fortrea.
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Proven leadership in global regulatory strategy for product development.
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Served on the Board of Directors of the College on Problems of Drug Dependence (CPDD) and currently serves on the CPDD Public Policy Committee.
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Chief Operations Officer of the Cross Company Abuse Liability Council (CCALC).
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Scientific Advisory Board Member
A well-thought regulatory strategy optimizes drug development.
Drug development is a complex, costly, non-linear process specific to each molecule and its respective therapeutic indication. Through the different phases of development, preclinical and clinical tests generate the body of results that will be submitted to regulatory agencies for evaluations of the new drug's efficacy and safety in the target population. These evaluations are the basis for the drug's regulatory approval and registration.
Defining the regulatory strategy at the start of the development is key for identifying the most efficient path towards the product registration.
In the highly dynamic and complex regulatory environment, success in developing a new drug largely depends on a well-defined and thought-out regulatory strategy.
The regulatory strategy is not just a bureaucratic requirement but the backbone of the drug development process.
A well-defined regulatory plan allows companies and institutions to optimize resources, reduce and mitigate risks, and maximize their chances of successfully achieving their commercial goals.
An efficient strategic regulatory approach involves:
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Starting with the end in mind - defining the Target Product Profile and the Clinical Development Plan – ensuring clear and precise objectives for each phase of development with respective key deliverables.
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Anticipating challenges and opportunities – identifying possible barriers, such as the need for additional studies, and innovative approaches, such as regulatory incentives and accelerated review mechanisms whenever appropriate.
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Identifying risk mitigation strategies – preparing contingency plans to minimize uncertainties and ensure the continuity of development, identifying Go/No Go decision points.
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Mapping out key engagements with regulators throughout the development process.
