Clinical, Medical Affairs, Pharmacovigilance & Medical Device Product Strategy Throughout the Life Cycle Management

Ahlyna has designed a new model for supporting and providing strategy for the needs of the clinical, scientific and medical functions within pharmaceutical and medical device companies throughout the life cycle management of their products. Our teams of experienced medical and scientific experts support our clients become more strategic and effective in achieving their goals.

Who We Are

Our teams consist of experienced medical and scientific experts who have the knowledge needed to solve the industry's most complex problems and the capability to execute and implement the processes to bring overall efficiency

Ahlyna Supports Small, Medium and Large Pharmaceutical and Medical Device Companies


Various therapeutic areas are supported by our physicians and scientific experts

Ahlyna Strategy Explained


Medical affairs is a core function within the Pharmaceutical industry where medicine, science, and business come together to provide scientific and medical expertise in communicating medical information and work alongside R&D, commercial and market access to focus on key strategic imperatives including Healthcare Professional (HCP) engagement, external partnerships, and data generation. Medical Affairs teams implement effective strategic decision making the strategies in real time to the changes in the pharmaceutical industry by gathering cross functional input, integrated evidence generation planning, adopting patient centricity and sustainability and interact with external stakeholders.

Medical Affairs has become a strategically critical function for the success of any pharma product and are responsible for educating internal and external stakeholders on scientific topics, care pathway and patient outcomes. They engage with external stakeholders into value and science discussions. it's imperative to focus on three key strategic imperatives: Healthcare Professional (HCP) engagement, external partnerships, and data generation.
Ahlyna supports most start-ups, small and mid-sized pharmaceutical, biotech, or medical device companies that lack the resources and the time to build a detailed research strategy and an extensive and precise roadmap to complete the clinical development process.

Ahlyna collaborates with its clients to design a successful clinical development strategy to identify optimized pathway, anticipate hurdles, and understand the market and product uniqueness. Ahlyna' strategic planning includes an efficient study design, preparation of protocol that will clearly reflect assessment criteria, number of subjects required, number of study sites, analyzing the inclusion and exclusion criteria, designing easy to read Informed Patient Consent forms etc.

The development strategy includes
Product risk assessment and market evaluation Pathway recommendation and country selection Study planning and protocol preparation, establish efficient and effective study protocols Identification of clinical investigators, research sites, etc.
Ahlyna supports regulatory strategy plans for regulatory submissions and regulatory agency interactions to obtain faster regulatory approvals and ensures clinical strategy benefits drug development. Strategic plans for regulatory submissions and regulatory agency interactions are crucial after each successful phase of the clinical trial. Proper monitoring and timely outcome assessment are critical to avoid regulatory submission delays and process failures. Ahlyna team have the expertise in working with various world-wide regulatory agencies including FDA, EMA, MHRA, PMDA, TGA, CDSCO, SFDA, LATAM agencies and MENA region agencies to support marketing approval of drugs.
Ahlyna with its team of pharmacovigilance experts suports product risk assessment and market evaluation throughout the product life cycle starting from pre-clinical studies until the drug is on the market to comply with the regulatory requirements. Throughout the life-cycle of the product pharmacovigilance strategy is achieved through continuous risk-benefit assessment and regulatory understanding. For high risk products Risk Management Plans and Additional Risk Mitigation Plans and Risk Evaluation and Mitigation Strategies are put in place to support the product.

Become Ahlyna's Partner

With an impeccable track record of quality and highly ethical practices, Ahlyna serves global clients that include start-ups, mid-sized enterprises and fortune 100 companies.

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