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.
Company Details
- Employees
- 3
- Founded
- -
- Address
- Alberton , Za
- Industry
- Business Consulting And Services
- NAICS
-
Management, Scientific, and Technical Consulting ServicesManagement Consulting ServicesOther Scientific and Technical Consulting ServicesOther Management Consulting Services
- Website
- http://www.ahadrikapharma.com
- Keywords
- Regulatory Intelligence, New medicines registration, Variations, Renewals, Due diligence, Gap analysis, Dissolution, Biostudies, Particle size, Polymorphism, Formulation development, Reformulation, Stability data, Efficacy data, Failing dissolution, Regulations, Dossier compilation, eSubmission, eCTD, RA training, Bioavailability, Analytical methods development, Analytical methods validation, Finished product manufacturing process, Finished product process validation, BCS, Biowaver, BTIF, QOS, QIS, APIM Procedure, SCoRE, Reliance pathways, Regulatory pitfalls, Regulatory deficienies, FP release.
- HQ
- Alberton
Ahadrika Pharma Questions
Ahadrika Pharma's website is http://www.ahadrikapharma.com
Ahadrika Pharma's LinkedIn profile is https://za.linkedin.com/company/ahadrikapharma
Ahadrika Pharma has
3 employees.
View email and phone details for 3
employees at Ahadrika Pharma.
Ahadrika Pharma's industry is
Business Consulting and Services
Ahadrika Pharma's top competitors are
Dyotatech.ai,
Kottas Pharma Gmbh,
L. Kögl Pharma Gmbh,
Pharma Bazzar Uk Ltd,
Metochem-Pharma Gmbh,
Ebewe Pharma Ges.m.b.h Nfg., Unterach Am Attersee,
Athletic Aesthetic,
Mitsubishi Pharma Deutschland Gmbh,
Ki Pharma Alliance,
Gw Pharma.
Ahadrika Pharma's categories are Business Consulting and Services
Ahadrika Pharma's founding year is 2022
