About Accredited consultants pvt. ltd.
Accredited Consultants Pvt. Ltd. (ACPL) is a regulatory consultant service provider based in Delhi, India. The company specializes in providing regulatory affairs, pharmacovigilance, clinical trial and medical writing services for drugs, medical devices, food and cosmetics.
With over a decade of experience in the industry, ACPL has established itself as one of the leading regulatory consultants in India. The company has a team of highly qualified professionals who are well-versed with the latest regulations and guidelines related to drug development and approval.
Regulatory Affairs Services
ACPL offers a wide range of regulatory affairs services to its clients. These include:
1) Regulatory strategy development: ACPL helps its clients develop an effective regulatory strategy that takes into account all relevant regulations and guidelines.
2) Regulatory submissions: The company assists its clients with preparing and submitting various types of regulatory submissions such as INDs (Investigational New Drug applications), NDAs (New Drug Applications), ANDAs (Abbreviated New Drug Applications), DMFs (Drug Master Files), etc.
3) Labeling review: ACPL provides labeling review services to ensure that the product labeling complies with all applicable regulations.
4) Post-approval maintenance: The company also helps its clients with post-approval maintenance activities such as annual reports, variations, renewals etc.
Pharmacovigilance Services
ACPL offers comprehensive pharmacovigilance services to ensure that its clients comply with all safety reporting requirements. These include:
1) Adverse event reporting: ACPL assists its clients with timely reporting of adverse events related to their products.
2) Signal detection: The company uses advanced signal detection techniques to identify potential safety issues associated with their client's products.
3) Risk management plans: ACPL develops risk management plans for their client's products based on the latest safety data available.
Clinical Trial Services
ACPL provides end-to-end clinical trial services to its clients. These include:
1) Protocol development: The company helps its clients develop a robust clinical trial protocol that meets all regulatory requirements.
2) Site selection and management: ACPL assists its clients with site selection and management activities to ensure that the clinical trial is conducted in compliance with all applicable regulations.
3) Data management: The company provides data management services to ensure that the data collected during the clinical trial is accurate, complete and consistent.
Medical Writing Services
ACPL offers a wide range of medical writing services to its clients. These include:
1) Clinical study reports: The company prepares high-quality clinical study reports that meet all regulatory requirements.
2) Investigator brochures: ACPL develops investigator brochures that provide comprehensive information about the client's product.
3) Scientific publications: The company also helps its clients prepare scientific publications such as manuscripts, abstracts, posters etc.
In conclusion, Accredited Consultants Pvt. Ltd. (ACPL) is one of the leading regulatory consultant service providers based in Delhi (India), for drugs, medical devices, food and cosmetics. With over a decade of experience in the industry, ACPL has established itself as a reliable partner for companies looking for expert guidance on regulatory affairs, pharmacovigilance, clinical trials and medical writing services. If you are looking for a trusted partner who can help you navigate through complex regulations related to drug development and approval process in India then look no further than Accredited Consultants Pvt. Ltd.!