We are doing works in all sections of the Drug Department being we are working for varied manufacturers & importers needless to mention about clinical trial permissions & import permits coupled with related departments such as DGFT, Animal Husbandry, Ministry of Science & Technology etc. To pinpoint, we work for several multinationals & we are even guiding many companies in preparing dossiers. You can consult us even before hand in case of any doubt in preparing the application. In other words we claim that our basis of consultancy is knowledge and that makes us a different consultant. We attempt to nurture & exploit the maximum possibilities of the law relating to the same. We generally look at the drug regulatory by the angle of custom’s laws to avoid future complicacies. We work professionally & not as an individual doing liaison, which is the common scenario otherwise. We believe in doing of works with knowledge and according to standards of Industry. We ensure 100% compliance with the laws of the land and other International laws like FCPA. We are professional company having good infrastructure, therefore, we are capable of doing things differently which is the basis and secret of our success in the Drug Regulatory Consultancy.
We are one of the companies which has the largest number of briefs on Diagnostics & Medical Devices Regulatory, hence our experience is vast. We too help in preparing Dossiers for obtaining Manufacturing Licenses, GMP etc, from respective State Drug Controller & Regional CDSCO.
We are into consultancy of getting accreditation such as NABH to hospitals, NABL to laboratories & other accreditation in the field of healthcare in various countries.
We have channel partners in the field of various consultancy & we are associated with other consultancy services. We help our esteemed clients and foreign companies to establish in India by providing the services of relevant professionals like a Company Secretary, a Chartered Accountant (Audit & Accounting works), a professional doing Market Study & other relevant works, a professional organization doing clinical trials, HR Consultants, CE Certification Consultant, ISO Accreditation Consultants and such other professionals as per requirement.
Special NOC’s/Approvals/Permissions/Waivers
Testing: Form 11,NOCs
Import Licenses, Registration
Dual Use NOC for drug (bulk and finished form), cosmetics, medical devices and kits
Change of Location
Renewal of Licenses/Extensions, Recertification
Documentation and Preparation of Dossier
Submissions at Regulatory Govt Offices in State FDA, CDSCO-Central, Zonal and Sub Zonal Offices,
DGFT, CDL/CDTL, NABL Testing’s
Submission of Govt fee for various Licenses, NOCs and Permissions
Submission, Meetings and Collection of Test Reports from Govt Labs Example NABL,CDTL/CDL etc
Technical and Regulatory Support for queries by Port Officers
Regulatory Consultancy: Related to matters of State Drug Control Offices, CDSCO-HQ Zonal and Sub Zonal Offices
Custom Regulatory Services
Wireless Products Permission from MOT
Permission from MOE, MOA, CIB, BIS
Others
Pharmacovigilance Services:
Strategic and operational benefit/risk safety services. We are provided the complete solutions for Pharmacovigilance as per regulatory requirement. ACPL is globally providing the full range of Pharmacovigilance services.
Management of case reports and adverse event reporting Individual Case Safety Report (ICSRs) Processing
Post‐Marketing Non‐Solicited/Spontaneous Reports
Clinical trial Reports:
Special Reports: Pregnancy reports etc.
Medical Device related Reports
Routine safety surveillance, signal detection and Management
Risk-benefit management and analysis
Risk Management Plans (RMPs)
Qualified Person for Pharmacovigilance (QPPV)
Aggregate/Periodic Report Writing & Submission (PSURs/PBRERs/PADERs/DSURs), IND annual safety reports etc.
Medical Writing Services/ Clinical & Regulatory Writing Services:
We provide Medical Writing Services entails the generation of well‐structured individual reports supporting Extensive medical writing programs, including
Aggregate & Periodic Report Writing (PSURs/PBRERs/PADERs/DSURs) & Submission
Pharmaceutical Risk Management Plans (RMPs)
SAE Narratives for Clinical Study Reports
Clinical Study Reports
Clinical Summaries/Product Feasibility Reports for Medical Devices
Annual safety report writing
Patient Diary Cards (PDC), Informed Consent Form (ICF), Case Report Forms (CRFs) etc.
Company Core Safety Information (CCSI), Company Core Data Sheet (CCDS), Summary of Product Characteristics (SmPC), Pack Insert and Local Labels
Detailed Description of Pharmacovigilance Systems (DDPS)
Literature and Brochure for medical devices
Proficiency in creating detailed NDA, ANDA and IND applications (Module 1 ,2,3,4 and 5)
Manufacturing License for Allopathic Drugs, Medical Devices and Cosmetics.
Manufacturing License/Loan License/Form 29
GMP/WHO GMP Certificate
Export NOCs
Free Sale Certificate
Neutral Code Certificate
Advance License
Site Audits
Renewal of Licenses, Certificates
R&D Recognition from DSIR
Legalization from Embassy & Notarization(Whenever Required)
Insecticide License/Pesticide License
Seeds License
Fertilizer License
Food License
Tread Mark
Patent
Copyright
Shop Establishment
Tread License
Labor License
PF and ESI Registration
Pollution NOC and License
Fire License
Corporate Contracts.
Employment Contracts
Others
Vix in voluptua expetendis, ea meis definitiones sea. Ea per dicat detraxit expetendis, vide saepe contentiones per id, ea labores maiorum eos. Cu quod vocent intellegat mei. Vis enim quaerendum complectitur ea, falli eleifend.
Mary Miller
Case dolore electram pro te, ius id saepe petentium. Vel omnesque pericula evertitur te, eros vivendo sententiae sea an. Ei vim enim definitiones, ut eam erant verear equidem. In virtute albucius appetere nam, qui in facer aliquam.
Arlie Bourland
Sed ut perspiciatis unde omnis iste natus error sit voluptatem accusantium doloremque laudantium, totam rem aperiam, eaque ipsa quae ab illo inventore veritatis et quasi. Lorem ipsum sit dolor polis
Helena Siemens