Regulatory Services and Registration
Prakhar provides services in Drug Regulatory Affairs. Our regulatory experts compile the dossiers (DMF, ASMF, APIMF, Dossier), publish in eCTD format through software and facilitate to file in regulatory agencies. Experts help the companies in addressing the deficiencies of regulatory agencies if requested during review of application.
Healthcare Regulatory Affairs team is a niche scientific and regulatory consulting group. We guide and assist pharmaceutical, biotech and healthcare companies in the design and implementation of innovative and global regulatory strategies in order to expedite product development and registration of drugs, biologics, medical devices, combination products for all stages of development.
Prakhar keeps the track of various changing trends in the market regarding the regulatory reforms. We always upgrade ourselves with the recent regulatory guidelines and norms, which is why we are the best to offer the satisfactory regulatory affairs consulting services to pharmaceutical industry. Our professional regulatory consultants are always in the quest for new reforms which is superbly beneficial for our clients.
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Third Party Manufacturing
Building a Stronger, Healthier Future Together!
Contract manufacture for other parties under their brand name. Conceptualize and provide your own brands in your Country and to provide all advertising inputs to enable you to earn better profits for you.- 100% quality assurance
- ISO, WHO & GMP Certified
- High-tech formulation
Audit and Traning
GMP Compliance | GMP Consultancy Services | GMP Audit Pharmaceutical | GMP Gap Analysis Audit | GMP Training | DMF/Dossier Preparation | cGMP Consulting Services | Quality Management Systems | Technical Document Writing
Prakhar has qualified auditors perform third party audits of manufacturers of Drug Products, Active Pharmaceutical Ingredients, Raw Materials, Packing Materials and Intermediates.
Pharmacovigilance
We support in Safety Monitoring and its assessment by providing support in:
- Pharmacovigilance system
- PSUR and RMP
- QMS Pharmacovigilance
- SmPC/PIL/Insert Writing
eCTD Publication and Reports
eCTD submission publishing, Electronic Submission Gateway and technical support for US, Canada and EU.
Scientific Writing:
- Nonclinical
- Toxicology Risk Assessments
- Clinical
Yoga and Certification
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In 2020, we made new long-term commitments to sustainable development.
Interested in partnering with us on your next project?
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