Biotech Regulatory Solutions is an established and highly experienced Australian based regulatory and medical/scientific affairs consulting business with a broad background in regulatory affairs, R&D, drug development, medical information and pharmacovigilance within the pharmaceutical industry.
In additional provide outsourcing options with regards to promotional material review, medical information and phamacovigilance activities.
With over 70 years combined experience in the pharmaceutical and allied sectors of the industry, Biotech Regulatory Solutions consultancy provides professional services tailored to assist your regulatory needs.
Biotech Regulatory Solutions provide professional, high quality service that is flexible and solution based to meet your needs. We provide the following regulatory consulting services:
> Prescription medicines – NCE, line
extensions, major variations and
general maintenance.
> Biotech medicines – new entities,
line extensions, major variations and
general maintenance.
> Biosimilar medicine registrations- with recent successful registations.
> Generic medicines – new generics,
bioequivalence study management
and general maintenance.
> OTC medicines – NMA, variations and
general maintenance.
> Dossier review – gap analysis reports.
> Medical Devices (Class II, IIa/b & Class I).
> Literature based submissions.
> Orphan drug submissions.
> NeeS/eCTD
> GMP assistance including SOPs and systems/process improvement. State Health Authority Licensing for distribution and supply.
> Import Permits.
Company Details
- Founded
- -
- Address
- Sydney, New South Wales
- Industry
- Pharmaceutical Manufacturing
- NAICS
-
Pharmaceutical and Medicine ManufacturingMedicinal and Botanical ManufacturingPharmaceutical Preparation ManufacturingIn-Vitro Diagnostic Substance ManufacturingBiological Product (except Diagnostic) Manufacturing
- Keywords
- Prescription medicines – NCE, Prescription medicines – Gx, Biotech medicines, OTC medicines, Quality Systems assistance (eg SOPs, vendor agreements), Dossier Gap Analysis, eCTD/NeeS, Literature Based Submissions, Biosimilars, Pharmacovigilance, Quality Assurance, Medical Information, Due Diligence, Sponsorship, Life Cycle Maintenance, Regulatory advise, Medical Devices, Extension of Indications, Baseline dossier.
- HQ
- Sydney, New South Wales
Biotech Regulatory Solutions Questions
Biotech Regulatory Solutions's website is http://www.biotechregulatory.com.au
Biotech Regulatory Solutions's LinkedIn profile is https://au.linkedin.com/company/biotech-regulatory-solutions
Biotech Regulatory Solutions's industry is
Pharmaceutical Manufacturing
Biotech Regulatory Solutions's top competitors are
Accestra Consulting,
Baxter Regulatory Solutions Llc,
Ascelon,
Regulatory Solutions Llc,
Wellington France,
Quantum Regulatory Solutions, Llc,
Biotech Investments,
Medical Device Regulatory & Quality Solutions,
Bham Pharma,
Regulatory Compliance Solutions Inc. "rcsi".
Biotech Regulatory Solutions's categories are Pharmaceutical Manufacturing
Biotech Regulatory Solutions's founding year is 1997
