About Ahadrika Pharma

At Ahadrika Pharma, it is not “We can’t do that”, but rather “How can we get it done?. We know that a vital commercial and strategic objective for Pharma companies is to accelerate patients’ access to high quality, safe, effective medicines, while maximising sustainable financial returns for stakeholders. Partner with Ahadrika Pharma to conceptualise, develop and register a new medicine with regulators or to reformulate an existing medicine and obtain timeous regulatory approval of the variation or renewal.

The registration or maintenance of registration of medicines is a highly regulated process with strict adherence to legislation and guidelines that are aimed at ensuring the safety, quality and efficacy of the medicines. Following submission of an application for new medicine registration or variation or renewal of a registered medicine, regulators assess the data submitted to ensure that the medicine is or remains fit for the intended purpose and does not pose risks to patients, due to inadequate quality, safety or efficacy guarantees.

During the evaluation process, regulators frequently observe pitfalls and deficiencies in regulatory submissions, which are then communicated to applicants for resolution before approval is granted. An application that generates a relatively large number of deficiencies often necessitates multiple interactions between the applicant and regulators, resulting in increased turnaround times for regulatory approval, impacting negatively on realisation of the commercial and strategic objective of the business, while delaying patients’ access to quality, safe and effective medicines.

At Ahadrika Pharma, we help Pharma businesses to anticipate or avoid common regulatory pitfalls and deficiencies that are frequently identified by regulators, using effective regulatory intel, science and risk-based strategies, that are intended to reduce the turnaround times for regulatory approval of new medicines, variations and renewals.