BDK Lifesciences Pvt. Ltd. Is a pharmaceutical regulatory Affairs consulting firm (PHARMA REGULATORY AND GMP CONSULTANT) based in Greater Noida, (Delhi-NCR) India. We give an extensive range of services in the areas of regulatory affairs for small to medium size pharmaceutical companies to help them to overcome the challenges within the rapidly growing global pharmaceutical market.
Preparation and submission of dossier in ICH-CTD, ACTD and REGIONAL format, GMP Certification, GMP Audits and Approvals, GAP Analysis, Drug Master File (DMF) Management, Medical Writing, Clinical Trials documentation, BE/ BA Studies, Medical Devices/Cosmetics Registration,
PHARMA REGULATORY SERVICES
DOSSIER PREPARATION SERVICES
BDK Lifesciences Pvt. Ltd. is a growing Global Pharmaceutical Regulatory Affairs and GMP Consultant based in India. Our team of experts prepare dossier as per CTD/ ACTD / non-CTD (country specific guideline) and maintain utmost promise of service with high quality.
WHO-GMP AUDITS, APPROVALS & CERTIFICATION SERVICES
We work with diverse base of companies and we are proud to work with different industries to whom we have been helping by GMP auditing & GMP Certification by doing the GAP analysis and finally helping them to comply with the stringent regulatory guidelines.
MEDICAL WRITING SERVICES
BDK Lifesciences Pvt. Ltd. is one of the growing Medical Writing Services providers. Our Medical Writing Services involve the Medical Writers who work closely with our colleagues in the, Biostatistical, Pharmacovigilance, project management, and Clinical Data Management teams to deliver accurate, timely, and cost effective documents to the highest ethical and scientific standards.
DRUG MASTER FILE (DMF) Services
BDK Lifesciences Pvt. Ltd provides the Drug Master File Services to the pharmaceutical companies to assist them in the regulatory filling process. Drug Master File (DMF) is a master document containing complete information on API. Drug Master File is a technical documents containing Chemistry, Manufacturing and Controls (CMC) of an Active pharmaceutical ingredient(API).
BA/BE STUDIES SERVICES
The Clinical Study team of BDK Lifesciences Pvt. Ltd. with extensive experience in clinical research provides services include project management, clinical conduct, clinical monitoring, pharmacy services and Medical Services including medical writing, monitoring and Safety reporting. Our Quality Assurance team independently monitors quality of all deliverable窶冱.
The proficient expert team of BDK Lifesciences Pvt. Ltd. prepares the following documents for clinical trials:-
Designs, implements and monitors clinical studies of compounds designated for clinical development. Develops protocols and case report forms, which will provide adequate efficacy and safety information for Phases 1 to 3 of clinical trials.
Cosmetics Registration : Our services include the following-
Conducting audits of cosmetic manufacturers to assure compliance with GMP guidelines
Evaluating the safety of cosmetic ingredients.
Preparing color additive petitions for submission to Regulatory Authority for approval.
Designing clinical studies to document safety of ingredients, and to substantiate label claims.
Serving as expert witnesses and providing testimony on litigation involving disputes over color/cosmetic regulatory matters.
Arranging and attending meetings with Agency officials on behalf of our clients.
Providing guidance on import procedures, import registration and assisting in obtaining clearance of products.
Providing management and employee training on color/cosmetic regulatory matters.
Providing recall advice and assistance as needed.
Reviewing cosmetic labeling for compliance with FDA requirements.
Regulatory Affairs Consulting : We provide complete solutions of registration from initial to final stage manufacturer / applicant for:
1. Dossier compilation as per:
ASEAN Common Technical Dossier (ACTD) Guidelines
Common Technical Documents as per ICH format
Regional Format (Country Specific)
2. Handling queries
3. Draft query reply
4. Registration Management
5. Documents Review
ﾃャﾃつ｢ﾃδｯﾃつｿﾃつｽﾃモﾃつ｢ BMR, MFR
ﾃャﾃつ｢ﾃδｯﾃつｿﾃつｽﾃモﾃつ｢ Process Validation reports
ﾃャﾃつ｢ﾃδｯﾃつｿﾃつｽﾃモﾃつ｢ Analytical Validation reports
ﾃャﾃつ｢ﾃδｯﾃつｿﾃつｽﾃモﾃつ｢ Stability Study reports,