Precision's Pharma is a team of experienced regulatory affairs consultants who specialize in pharmaceutical and medical device regulatory affairs. They are highly skilled in compiling dossiers for global regulatory authorities in CTD, eCTD, ACTD, and country-specific formats for the CIS Countries, ASEAN, AFRICAN, Middle East, Latin American (Latam), and ROW markets.
We provide regulatory framework support to the pharmaceutical and healthcare industries throughout the regulatory chain, from regulatory strategy, intelligence, dossiers, and submissions to post-approval, product maintenance, query resolution, artwork management, and other associated tasks.
We offer an effective solution for both short- and long-term regulatory or compliance needs.
Our services include, but are not limited to:
Country Specific Dossiers
CTD Dossiers Compilation
ACTD Dossiers Compilation
eCTD Dossiers Compilation
eCTD Dossiers submission
ANDA (Abbreviated new drug application)
USFDA product registration
CTD DMF Services
eCTD DMF Services
Site Master Files (SMF)
Comparative Dissolution Profile (CDP)
BE/BA Study
Query Resolution
Stability Study Reports
Artwork Management
Risk Management Plan (RMP)
Periodic safety update report (PSUR)
Analytical Method Validation (AMV)
Product Development Report (PDR)
Process validation Report (PV)
SOP preparation
Preparation of documents and Audit as per WHO/GMP guidelines
We are now working with a variety of small to large-scale firms to provide regulatory services for securing approval or registration of their products in global markets, and we are extremely eager to serve you and your organization!
Company Details
- Employees
- 2
- Founded
- -
- Address
- Science City Road, Ahmedabad,gujarat 380060,india
- Industry
- Pharmaceutical Manufacturing
- NAICS
-
Pharmaceutical and Medicine ManufacturingMedicinal and Botanical ManufacturingPharmaceutical Preparation ManufacturingIn-Vitro Diagnostic Substance ManufacturingBiological Product (except Diagnostic) Manufacturing
- Keywords
- Analytical Method Validation (AMV), BE/BA study, Process validation Report (PV), Comparative Dissolution Profile (CDP), Country Specific Dossiers, ANDA (Abbreviated new drug application), USFDA product Registration, Site Master Files (SMF), Drug Master File (DMF), Stability Study Reports, Periodic safety update report (PSUR), Product Development Report (PDR), SOP preparation, Risk Management Plan (RMP), Artwork Management, Preparation of documents and Audit as per WHO/GMP guidelines..
- HQ
- Ahmedabad, Gujarat
Precision Pharma Regulatory Services Questions
Precision Pharma Regulatory Services's LinkedIn profile is https://in.linkedin.com/company/precision-pharma-regulatory-services
Precision Pharma Regulatory Services has
2 employees.
View email and phone details for 2
employees at Precision Pharma Regulatory Services.
Precision Pharma Regulatory Services's industry is
Pharmaceutical Manufacturing
Precision Pharma Regulatory Services's top competitors are
Saga Lifesciences Limited,
Pharmalliance,
Immacule Lifesciences,
Troikaa Pharmaceuticals Ltd.,
Precision Pharmaceuticals, Inc.,
Precision Pharmacy Inc.,
Biological E. Limited,
Isazi,
Akshar Global Clinical Research (Agcr),
Pharmazone.
Precision Pharma Regulatory Services's categories are Pharmaceutical Manufacturing
Precision Pharma Regulatory Services's founding year is 2022
